MinTankesmie

- Senator Grassley sier GlaxoSmithKlines (GSKs) hemmeligholdt legemiddeldata

Prof’s study linked to child suicide (Professor linket til barne-selvmord)
browndailyherald.com 17.11.2011
U. remains silent in face of accusations

Ten years after its publication, a study by Professor of Psychiatry and Human Behavior Martin Keller continues to generate concern in the medical community due to its alleged link to child suicide.

Last month, the global nonprofit Healthy Skepticism wrote to the University requesting support for its efforts to retract Keller's article — commonly known as Study 329 — from the Journal of the American Academy of Child and Adolescent Psychiatry.

Healthy Skepticism expressed concern that the study, which identified the drug Paxil as an effective combatant of depression in children, "seriously misrepresented both the effectiveness and the safety" of the drug. The authors added that the study's continued citation was harmful to children, since some children committed suicide after being prescribed Paxil.

The letter follows several ethical examinations of Study 329, including a BBC documentary, the book "Side Effects" by former Boston Globe reporter Alison Bass and an investigation by the Senate Finance Committee. Those inquiries led to allegations that the authors of the study — who had received funds from Paxil's parent company GlaxoSmithKline — suppressed the findings on the drug's connection to suicidal tendencies because they would adversely affect profits.

Keller, the lead author, was also accused of allowing the study to be ghostwritten by a GlaxoSmithKline affiliate. In June 2009, he stepped down as chair of the psychiatry department, citing personal reasons, but he retained his professorship. Keller did not respond to multiple requests for comment for this story.
Citing confidentiality reasons, Dean of Medicine and Biological Sciences Edward Wing also declined to comment. (...)

(Anm: Antidepressiva (nytteverdi) (mintankesmie.no).)

Grassley Says Glaxo Withheld Drug Data (Grassley sier Glaxo hemmeligholdt legemiddeldata)
online.wsj.com 13.7.2010
WASHINGTON—A former Food and Drug Administration official said the maker of diabetes drug Avandia withheld from regulators information suggesting the drug posed an increased risk for serious heart problems, according to people familiar with her statements.

The allegation comes as one of the biggest recent drug-safety fights nears a climax. Starting Tuesday, a panel of FDA experts will debate whether GlaxoSmithKline PLC's Avandia should be pulled from the market after years of controversy over its alleged side effects.

The statements by the ex-FDA official, made in a deposition for lawsuits filed against Glaxo, are included in a letter received Monday by the agency from Sen. Charles Grassley (R., Iowa), the top Republican on the Senate Finance Committee, which has been investigating Glaxo and Avandia. His letter, co-signed by committee chairman Sen. Max Baucus (D., Mont.), includes additional information detailing internal company records about Avandia, according to people familiar with the letter. (...)

(Anm: Legemiddelstudier, åpenhet, uredelighet og kvalitet. (mintankesmie.no).)

GSK's bitter sweet pill to swallow (GSKs svelger bittersøt pille)
thisismoney.co.uk 13.7.2010
After BP's rough treatment in Washington, GlaxoSmith-Kline, one of Britain's world class pharmaceutical groups, cannot take the current regulatory hearings on its key diabetes drug Avandia lightly.

In much the same way as BP became a victim of the American debate about the advisability of deep-sea drilling for oil, so the food & Drug Administration hearings into Avandia could become something more serious.

One of the few legislative victories for Barack Obama has been healthcare reform. Among the goals of that reform was to cap the cost of pharmaceuticals, which form a large chunk of America's big health bill.

It would be grotesque if GSK - which sought to clear up its act in the wake of the Paxil/Seroxat controversy - were now to be dragged through the mud over Avandia. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Glaxo Plans $2.3 Billion Liability Charge (Glaxo avsetter 2,3 milliard dollar til erstatningsansvar)
nytimes.com 15.7.2010
Det britiske legemiddelfirmaetGlaxoSmithKline uttalte torsdag at de tar et tap i andre kvartal på 2,36 milliarder dollar relatert til rettslige saker som involverer Avandia og Seroxat (Paxil). (...) (GlaxoSmithKline, the British pharmaceutical company, said on Thursday that it would take a second-quarter charge of $2.36 billion related to legal cases involving its drugs Avandia and Paxil.)

(Anm: Antidepressiva (SSRI) (mintankesmie.no).)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

Glaxo takes £1.57bn charge for Avandia, Paxil (Glaxo setter av 1,57 milliarder pund for anklager mot Avandia og Seroxat (Paxil))
telegraph.co.uk 15.7.2010
GlaxoSmithKline, the British drug maker, is to take a £1.57bn charge to cover settlements and legal actions relating to its diabetes pill Avandia and antidepressant Paxil.

With respect to Paxil and Avandia, the charge includes provisions for settled cases and an estimate for outstanding cases. Terms of the settlements reached are confidential, Glaxo said. (...)

Glaxo Said to Have Paid $1 Billion in Paxil Suits (Update2) (Glaxo hevdes å ha betalt 1 milliard dollar i forbindelse med Seroxat-søksmål)
Bloomberg.com 14.12.2009
Dec. 14 (Bloomberg) -- GlaxoSmithKline Plc has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to the people and court records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst at Matrix Corporate Capital in London. “I don’t think this is within the boundaries of current assumptions for analysts.” (...)

GlaxoSmithKline Reportedly Paid $1 Billion for Paxil Lawsuits (GlaxoSmithKline har angivelig betalt én milliard dollar for Seroxat-søksmål)
lawyersandsettlements.com 14.12.2009
Philadelphia, PA: According to reports, Paxil-maker GlaxoSmithKline may have paid almost $1 billion to settle Paxil lawsuits alleging serious side effects, including birth defects, addiction and suicides or attempted suicides. (...)

With 600 birth defects lawsuits still waiting in the wings, a $2.5 million settlement for each lawsuit could leave GlaxoSmithKline on the hook for $1.5 billion in birth defect lawsuits alone.

According to Bloomberg, approximately 150 suicide-related lawsuits were settled for an average of $2 million and 300 suicide attempt cases were settled for an average of $300,000. Meanwhile, 10 birth defect lawsuits were settled for an average of $4 million. (...)

Glaxo Ordered to Pay $2.5 Million for Paxil Defects (Update3)
(Glaxo dømt til å betale 2,5 millioner dollar for Seroxat-fødselsskader)
Bloomberg.com 13.10.2009
Oct. 13 (Bloomberg) -- GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial. (...)

GSK to Pay $2.5 Million to Family in Birth Defects Lawsuit (GSK betaler 2,5 millioner dollar til familie for Seroxat-fødselsdefekter)
lawyersandsettlements.com 13.10.2009
(...) Interne GSK-e-poster indikerer at de visste (Internal GSK Emails Suggest They Knew)

Under rettssaken ba dommeren GSK om å overlevere e-poster skrevet av GSK-ledere, og en slik e-post, et notat skrevet av Bonnie Rossello i 1997, som var spesielt belastende, inneholdt uttalelsen, "Dersom negative, resultater kan begraves." Rosello refererte til hva den farmasøytiske giganten burde gjøre dersom det ble nødvendig å utføre dyrestudier på Seroxat (Paxil), kjent som paroxetine (paroksetin). Ifølge resultater utført av danske utviklere av den kjemiske forbindelsen, tok lave doser av paroxetine livet av unge rotter. (During the court case the judge ordered GSK to hand over emails written by GSK executives, and one such email, written by Bonnie Rossello in a 1997 memo, was particularly incriminating, including the statement, "If neg, results can bury." Rosello was referring to what action the pharmaceutical giant should take if it became necessary to do animal studies with Paxil, known generically as paroxetine. According to results of a study done by the Danish developers of the compound, low-dose paroxetine killed young rats.)

Under rettssaken, fortalte Tracey jurymedlemmene at Food and Drug Administration (FDA) ikke ba om ytterligere sikkerhetsstudier for selektive serotoninreopptakshemmere (SSRIer) - den klasse antidepressiva som Seroxat tilhører - før i 2003. På dette tidspunkt erkjente angivelig GSK at Seroxat var assosiert med en økt risiko for fødselsdefekter. (...) (During the trial, Tracey reportedly told jurors that the Food and Drug Administration (FDA) did not order additional safety studies on selective serotonin reuptake inhibitors (SSRIs)- the class of antidepressants to which Paxil belongs - until 2003. At that point, GSK allegedly acknowledged there was an increased risk of birth defects associated with Paxil.)

Glaxo must pay $2.5M in Paxil case (Glaxo må betale 2,5 millioner dollar i Seroxat-sak)
philly.com 13.10.2009
GlaxoSmithKline P.L.C. must pay $2.5 million to settle a claim that its Paxil antidepressant caused severe heart defects in a 3-year-old Bensalem boy, a Philadelphia common pleas jury ruled today.

The verdict is the first in 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to boost profits.

The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo's total revenue. (...)

Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study (Selektive serotoninreopptakshemmere i svangerskap og medfødte misdannelser: befolkningsbasert kohortstudie)
BMJ 2009;339:b3569 (23 September)
(...) Konklusjon Der er en økt forekomst av defekter i hjerteskillevegger hos barn av mødre forskrevet SSRI tidlig i svangerskapet, spesielt sertraline og citalopram. Den sterkeste forbindelsen ble påvist hos barn av kvinner som innløste forskrivninger på mer enn én type SSRI. (...) (Conclusion There is an increased prevalence of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy, particularly sertraline and citalopram. The largest association was found for children of women who redeemed prescriptions for more than one type of SSRI.)

(Anm: Fosterskader (legemiddelinduserte) (mintankesmie.no).)

Selective serotonin reuptake inhibitors and congenital malformations
Editorials
BMJ 2009;339:b3525 (23 September)
(...) In the linked population based cohort study from Denmark (doi:10.1136/bmj.b3569), Pedersen and colleagues confirm a previously reported doubling of risk for septal heart defects after early exposure in pregnancy to SSRIs (odds ratio 1.99, 95% confidence interval 1.12 to 3.53).⁴ (...)

Lack of consistency across these studies with respect to specific malformations and specific drugs makes it difficult to translate the findings into clinical practice. (...)

One explanation for this inconsistency, assuming that SSRIs do cause specific birth defects, is differences in study designs. For example, although Pedersen and colleagues linked records for 496 881 singleton live born infants, they identified only 1370 mothers who redeemed multiple prescriptions for an SSRI in the perinatal period. Therefore, the study may have been insufficiently powered to detect the previously suggested twofold to threefold increased risk for anencephaly, omphalocele, craniosynostosis, or right ventricular outflow tract defects, all of which occur at least an order of magnitude less frequently than septal defects. (...)

Glaxo Linked Birth Defect of Fetus to Paxil, Ex-Executive Says (Ifølge tidligere leder linket Glaxo Seroxat til fødselsdefekter hos foster)
bloomberg.com 18.9.2009
Sept. 18 (Bloomberg) -- Officials of GlaxoSmithKline Plc, the U.K.’s largest drugmaker, said in 2001 that a birth defect in the fetus of a woman taking its Paxil antidepressant likely was linked to the drug, according to court testimony.

After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury. (...)

(Anm: Antidepressiva kan skade menns fruktbarhet (DNA), ifølge studie (mintankesmie.no).)

Glaxo Official Memo Official Scientists to Withhold Information About Paxil's Risks,... (Offisielt notat viser at Glaxo oppfordret forskere til å hemmeligholde informasjon om risiko ved Seroxat,...)
reuters.com 16.9.2009
Glaxo Official Memo Urged Scientists to Withhold Information About Paxil's
Risks, Trial Hears; Pharmaceutical Industry Today Offers Complete News
Coverage

ASHINGTON, Sept. 16 /PRNewswire-USNewswire/ -- Antidepressant drug Paxil,
which generated about 2.1% of GlaxoSmithKline's total revenue last year, has
been known to cause birth defects, but the world's second-biggest drugmaker
hid its risks to pump up profits, a Philadelphia court has heard.

According to available information, Glaxo failed to properly test the drug and
urged scientists to conceal Paxil's risks. The Philadelphia trial is the first
of more than 600 cases against the London-based company. (...)

Summary Box: Glaxo used ghostwriting to push Paxil (Oppsummering: Glaxo brukte spøkelsesforfattere (skjulte bidragsytere) til å pushe Seroxat)
forbes.com 19.8.2009 (AP)
British drugmaker GlaxoSmithKline PLC used a ghostwriting operation called CASPPER to promote its antidepressant Paxil, allowing doctors to take credit for journal articles mainly written by company consultants, according to court documents.

Here are some details from the memo, which instructs salespeople to approach physicians and offer to help them write and publish articles in medical journals:

_ The company offers to help doctors with everything from "developing a topic" to "writing a first draft."

_ The program's goal is to "strengthen the product positioning and overcome competitive issues."

_ The company expects that "physicians will be eager to participate in CASPPER regardless of their professional stature," adding "less experienced physicians may be interested in building their reputation in the field." (...)

(Anm: Spøkelsesforfattere (ghostwriters) (mintankesmie.no).)

Inside GSK's CASSPER Ghostwriting Program
industry.bnet.com 21.8.2009
A look inside GlaxoSmithKline’s CASSPER ghostwriting brochure reveals that Paxil Product Management at GSK expected its drug sales reps to control the process, even with doctors who were clearly unfamiliar with existing published data on the drug.

BNET noted yesterday that GSK (formerly SmithKline Beecham in the U.K.) maintained the program to create ghostwritten medical journal articles about its antidepressant, Paxil. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Glaxo used ghostwriting program to promote Paxil (Glaxo brukte spøkelsesforfatter-program for å promotere Seroxat)
google.com/hostednews/ap 19.8.2009 (AP)
WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication." (...)

Glaxo used ghostwriting program to promote Paxil (Glaxo brukte spøkelsesforfattere (skjulte bidragsytere) til å pushe Seroxat)
google.com/hostednews/ap 19.8.2009 (AP)
WASHINGTON — Court documents show drugmaker GlaxoSmithKline used a ghostwriting program to promote its antidepressant Paxil, letting doctors take credit for medical journal articles written by company consultants.

An internal company memo instructs salespeople to offer to help physicians write and publish articles about their positive experiences prescribing Paxil.

The document was uncovered by the Los Angeles law firm, Baul and Hedlund, which alleges Glaxo downplayed the risks of the drug, including increased suicidal behavior in young adults.

The April 2000 memo states that the program aimed to "strengthen the product positioning and overcome competitive issues," facing Paxil.

A spokeswoman for the British drugmaker had no immediate comment Wednesday afternoon. (...)

Glaxo used ghostwriting program to promote Paxil (Glaxo brukte spøkelsesforfattere (skjulte bidragsytere) til å pushe Seroxat)
google.com/hostednews/ap 19.8.2009 (AP)
WASHINGTON — Court documents show drugmaker GlaxoSmithKline used a ghostwriting program to promote its antidepressant Paxil, letting doctors take credit for medical journal articles written by company consultants.

An internal company memo instructs salespeople to offer to help physicians write and publish articles about their positive experiences prescribing Paxil.

The document was uncovered by the Los Angeles law firm, Baul and Hedlund, which alleges Glaxo downplayed the risks of the drug, including increased suicidal behavior in young adults.

The April 2000 memo states that the program aimed to "strengthen the product positioning and overcome competitive issues," facing Paxil.

A spokeswoman for the British drugmaker had no immediate comment Wednesday afternoon. (...)

GSK Used Ghostwriting to Push Paxil (GSK Glaxo brukte spøkelsesforfattere (skjulte bidragsytere) til å pushe Seroxat)
pharmpro.com 21.8.2009
WASHINGTON (AP) — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press. (...)

Court documents show Glaxo used CASPPER (the friendly ghostwriting program) to promote Paxil
latimes.com 19.8.2009
WASHINGTON (AP) — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects. (...)

CASPPER, GlaxoSmithKline’s Friendly Ghostwriting Program
online.wsj.com 23.8.2009
Drug makers have been taking heat for a while now over ghostwritten articles in medical journals. Basically, there have been instances where drug companies went out and found doctors willing to put their names on articles that the company paid someone else to write or make significant contributions to. (...)

Inside GSK's CASSPER Ghostwriting Program
industry.bnet.com 21.8.2009
A look inside GlaxoSmithKline’s CASSPER ghostwriting brochure reveals that Paxil Product Management at GSK expected its drug sales reps to control the process, even with doctors who were clearly unfamiliar with existing published data on the drug.

BNET noted yesterday that GSK (formerly SmithKline Beecham in the U.K.) maintained the program to create ghostwritten medical journal articles about its antidepressant, Paxil. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Investigation of Glaxo's Paxil widens: paper (Granskning av Glaxos Seroxat utvides, ifølge avis)
reuters.com 20.6.2008
NEW YORK (Reuters) - A U.S. Department of Justice investigation into whether GlaxoSmithKline PLC withheld data about the suicide risks of the antidepressant drug Paxil is widening, the Wall Street Journal reported on Friday.

In its online editions, the newspaper said Glaxo confirmed that a previously disclosed Colorado-based investigation of its marketing practices also includes the U.S. attorney's office in Boston and is being coordinated by the agency in Washington.

Federal investigators in Boston last year asked lawyers for families that are suing Glaxo for information, documents and depositions concerning Paxil's potential link to suicidal behavior, and how the company portrayed that risk to doctors and the Food and Drug Administration. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: Grassley seeks FDA scrutiny of Paxil and suicide risk (finance.senate.gov).

(Anm: Sen Grassley investigates GlaxoSmithKline and Paxil/Seroxat (seroxatsecrets.wordpress.com).)

UPDATE 3-US senator seeks FDA probe of Glaxo's Paxil data (Oppdatering 3- Amerikansk senator ber FDA granske Glaxos Seroxat-data)
reuters.com 12.6.2008
(Adds scientist comment, report details)
WASHINGTON, June 12 (Reuters) - U.S. Sen. Charles Grassley asked regulators on Thursday to investigate whether drugmaker GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research, Stock Buzz)(GSK.N: Quote, Profile, Research, Stock Buzz) withheld data about a risk of suicide linked to its anxiety disorder drug Paxil.

Grassley, a Republican from Iowa, said in a letter that a British regulatory agency had found that Glaxo knew as far back as 1998 that Paxil was associated with a higher risk of suicidal behavior in adolescents.

"I would like you to take a look at the information that agency gathered and determine if the company has withheld safety information here as well," Grassley wrote in the letter to the heads of the U.S. Department of Health and Human Services and the Food and Drug Administration.

Grassley also asked the FDA to review a report by a Harvard psychiatrist who had submitted information as part of several lawsuits.

Rapporten viste at Glaxo "måtte vite om Seroxats selvmordsrisiko da de søkte godkjenning for legemidlet," ifølge en meddelelse fra senatoren. (...) (The report found that Glaxo "had to know of Paxil's suicide risk when it sought FDA approval for the drug," a statement from the senator said.)

GlaxoSmithKline faces US scrutiny over Paxil suicide link (GlaxoSmithKline står overfor amerikansk granskning av Seroxats selvmordslink)
guardian.co.uk 12.6.2008
(...) The senator also pointed to a report recently unsealed by a US court that found GSK knew as early as 1989 that Paxil carried a heightened suicide risk in adults as well as children.

The report, by Harvard University psychiatrist Joseph Glenmullen, was based on internal GSK documents and intended for use in ongoing US court cases against the company. (...)

Sen. Grassley Asks FDA to Probe Glaxo Communication on Paxil (Senator Grassley ber FDA om granskning av Glaxo kommunikasjon om Seroxat)
blogs.wsj.com 12.6.2008
Sen. Chuck Grassley wants the FDA to dig in on the data that GlaxoSmithKline submitted to the agency about the antidepressant Paxil to know if the company concealed risk of suicide for users of the drug.

The Iowa Republican wants to know who knew what when about the medicine and a link to an increase in suicidal behavior.

Grassley points out in a letter to the agency and HHS Secretary Michael Leavitt that the U.K. recently concluded that GSK withheld safety information in its submission for approval in Europe, and wants the FDA to investigate whether the company did the same in the U.S. as well. (...)

Sen. Grassley Letter to Pharmaceutical Drug Maker About Notice of Drug Trial Findings (Senator Grassleys brev til legemiddelprodusent om bemerkninger til konklusjoner i legemiddelforsøk)
pharmalive.com 6.2.2008
WASHINGTON, February 6, 2008 - Sen. Chuck Grassley is asking drug maker GlaxoSmithKline for documents regarding the antidepressant medication Paxil. Sen. Grassley is making his request based on a review of documents recently made public and reported today in the magazine New Scientist. (...)

The publicly available portions of the report on Paxil that is missing nine pages is posted at http://finance.senate.gov along with this press release. (...)

(Anm: Grassley Press (finance.senate.gov).

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Did GSK trial data mask Paxil suicide risk? (Hemmeligholdt GSK selvmordsrisiko for Seroxat?)
newscientist.com 6.2.2008
AN INAPPROPRIATE analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, suggest court documents (897kb, requires Acrobat Reader) released last month. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

“Not until 2006 did GlaxoSmithKline alert people to raised suicide risks associated with Paxil/Seroxat” (...)

Paxil Risks at Center of Grassley Probe (Farer ved Seroxat i fokus for Grassley-granskning)
forbes.com 6.2.2008
WASHINGTON - A leading Republican senator is investigating whether GlaxoSmithKline knew about the suicide risks of its antidepressant Paxil more than 15 years before it warned the public.

The British drug maker added warnings to Paxil in 2006 about increased rates of suicidal behavior in young adults. However, Sen. Charles Grassley of Iowa said Wednesday that court documents from a recently dismissed lawsuit suggest the company knew about the risks as early as 1989.

In the documents, a Harvard Medical School psychiatrist argues Glaxo mishandled reports of suicide in early studies of Paxil. Glaxo has denied any wrongdoing. (...)

Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials
CMAJ 2008; 178 (3) (January 29)
Background: Concern has been raised about the efficacy of antidepressant therapy for major depression in adults. We undertook a systematic review of published and unpublished clinical trial data to determine the effectiveness and acceptability of paroxetine. (...)

Interpretation: Among adults with moderate to severe major depression in the clinical trials we reviewed, paroxetine was not superior to placebo in terms of overall treatment effectiveness and acceptability. These results were not biased by selective inclusion of published studies. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Paxil Risks at Center of Grassley Probe (Farer ved Seroxat i fokus for Grassley-granskning)
money.cnn.com 6.2.2008
Grassley Raises Questions About When Glaxo First Knew of Paxil's Suicide Risks

NEW YORK (Associated Press) - A leading Republican senator is investigating whether GlaxoSmithKline knew about the suicide risks of its antidepressant Paxil more than 15 years before it warned the public.

The British drug maker added warnings to Paxil in 2006 about increased rates of suicidal behavior in young adults. However, Sen. Charles Grassley of Iowa said Wednesday that court documents from a recently dismissed lawsuit suggest the company knew about the risks as early as 1989.

In the documents, a Harvard Medical School psychiatrist argues Glaxo mishandled reports of suicide in early studies of Paxil. Glaxo has denied any wrongdoing. (...)

If the company had tabulated the suicide reports conventionally, Glenmullen says the data would have shown Paxil patients had an eight times greater risk of suicidal behavior. (...)

- Parlamentsmedlem kritiserer legemidler under avhør om dødsårsak

MP takes war on drugs to inquest (Parlamentsmedlem kritiserer legemidler under avhør om dødsårsak)
torontosun.com 18.6.2010
Oakville MP Terence Young started a relentless campaign to prevent tragedies linked to prescription drugs when his teenaged daughter died after taking a since-banned drug Prepulsid for bloating in 2000.

He used a coroner’s inquest Friday to champion a host of changes aimed at protecting Canadians by making them aware of the dangerous side effects of prescription drugs.

The 57-year-old MP testified at the inquest examining the May 6, 2007 suicide of athlete-scholar Sara Carlin after the 18-year-old took an anti-depressant drug called Paxil.

Her parents are blaming the drug for her death.

Sara hanged herself in the basement of her parents’ Oakville home after taking Paxil for 14 months.

Young emphasized that patients must be educated about the dangerous side effects of drugs and the possibility of using alternate non-drug treatments. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

- Flere spørsmål om Seroxats (Paxils) sideeffekter (- Glaxo unnlot å advare om Seroxat-risiko)

Antidepressant Use During Pregnancy Linked to Higher Risk of Autism (Bruk av antidepressiva under svangerskapet linket til høyere risiko for autisme)
healthland.time.com 5.7.2011 (Time)
Children whose mothers use antidepressants during pregnancy may be more likely to develop autism than kids whose mothers do not, say researchers in California.

In a study involving data on more than 1,800 children — fewer than 300 of whom had an autism spectrum disorder (ASD) — and their mothers, the scientists found that women who were prescribed drugs to treat depression in the year before giving birth were twice as likely to have children with an ASD, compared with women who did not take antidepressants. The risk was even greater for women who were prescribed the drugs in the first trimester: their children were nearly four times more likely to develop autism or a related disorder.

The study focused on one type of antidepressant, selective serotonin reuptake inhibitors (SSRIs), a class of drug that includes fluoxetine (Prozac), paroxetine (Paxil) and sertraline (Zoloft). These antidepressants work by increasing available levels of the neurotransmitter serotonin surrounding nerve cells in the brain, which helps boost mood. (...)

Antidepressant Use During Pregnancy and Childhood Autism Spectrum Disorders (Bruk av antidepressiva under svangerskapet og autisme)
Arch Gen Psychiatry 2011 (Published online July 4)
(...) Results Prenatal exposure to antidepressant medications was reported for 20 case children (6.7%) and 50 control children (3.3%). In adjusted logistic regression models, we found a 2-fold increased risk of ASD associated with treatment with selective serotonin reuptake inhibitors by the mother during the year before delivery (adjusted odds ratio, 2.2 [95% confidence interval, 1.2-4.3]), with the strongest effect associated with treatment during the first trimester (adjusted odds ratio, 3.8 [95% confidence interval, 1.8-7.8]). No increase in risk was found for mothers with a history of mental health treatment in the absence of prenatal exposure to selective serotonin reuptake inhibitors.

Conclusion Although the number of children exposed prenatally to selective serotonin reuptake inhibitors in this population was low, results suggest that exposure, especially during the first trimester, may modestly increase the risk of ASD. The potential risk associated with exposure must be balanced with the risk to the mother or fetus of untreated mental health disorders. Further studies are needed to replicate and extend these findings. (...)

Can an increased risk of autism be linked to Paxil? (Kan en øket risiko for autisme linkes til Seroxat (paroxetine)?)
central-pennsylvania.injuryboard.com 15.3.2012
Late last year, a study was published in the Archives of General Psychiatry that suggests a possible link between autism spectrum disorders (ASDs) and maternal use of antidepressant medications during pregnancy. The study—although inconclusive as to a causal link between the two—has gotten quite a bit of attention for the advances it makes in furthering our understanding of what causes ASDs.

The study was aimed at determining whether prenatal exposure to antidepressant medications can be associated with an increased risk of ASD. It was a relatively small study, involving only about 300 children with ASD and 1500 randomly selected children without ASD. The authors concluded that the results suggest that exposure to SSRIs—especially during the first trimester—may “modestly increase the risk of ASD.” The researchers also underscored the need for further studies on this issue, particularly given this study’s small size. (...)

SSRI's And Environment Strong Autism Contributing Factors Over Genes
Editor's Choice
medicalnewstoday.com 5.7.2011
New research this week points to a link between the use of selective serotonin reuptake inhibitors (SSRIs), a type of antidepressant, and the occurrence of autism in unborn kids. Another study found that among twins, the environment plays a bigger role in the development of autism than genetics which is a game changer considering past investigation into autism cause factors.

Over the past 30 years, the number of children with autism has increased from about 4 in 10,000 to about 40 in 10,000.

First off, research led by Kaiser Permanente Northern California reviewed the medical records of more than 1,600 children, 298 of whom had autism spectrum disorders (ASDs). They found that the risk of having a child with autism spectrum disorder was about twice as high among women who took SSRIs in the year before delivery. That risk was even four times higher in women who took SSRIs during their first trimester. SSRIs include such well-known brands as Prozac, Zoloft, Paxil and Celexa. (...)

Data Confirm Trend of Sharp Rise in ASD Cases (Data bekrefter trend med sterk økning av autismetilfeller)
Psychiatr News 2011;46(14):20 (July 15) (American Psychiatric Association)
Among 388,644 children born in one state from 2001 to 2005, more than 3,000 were enrolled in an early-intervention program for autism spectrum disorders by age 3, and in that period, the numbers rose steeply.

In a reflection of national trends, a recent study of children in Massachusetts reports that diagnoses of autism spectrum disorders (ASDs) are increasing, particularly among boys. The study was published online May 16 in Pediatrics. (...)

They discovered that 1 of every 129 children born in Massachusetts in that five-year period was enrolled in an early intervention for an ASD by age 36 months. Early ASD diagnoses increased linearly from 1 in 178 for the 2001 birth cohort to 1 in 108 for the 2005 birth cohort, an increase of 66 percent. (...)

Serotonin and the Autisms (Serotonin og autisme)
Arch Gen Psychiatry 2011 (Published online July 5)
A Red Flag or a Red Herring?

The struggles to provide mechanistic insight regarding the causes of the autisms (autism spectrum disorder [ASD]) continue as the data mount from the newest population-based studies finding that ASD diagnoses affect 1% to 2% of the population.^1-2 Twin and sibling studies support the highly heritable nature of ASD risk, and at-risk younger siblings may have a recurrence risk of 15% to 20%. The newest estimates concur that rare mutations and copy number variants may account for up to 20% of cases.³ What about the other 80%? The genomecentric emphases have resulted in an opacity regarding the idea that through enhanced risk and/or endophenotype modulation, environmental factors are likely to interact with genetic components to participate at some important level in ASD etiology. Yet, the generation of convincing evidence of specific environmental factors remains a struggle, with the few exceptions of medication (eg, valproate sodium) or prenatal infection. Co-occurrence does not impart guilt, so the many candidates identified based on increases of exposures to a variety of agents that parallel an increase in ASD prevalence remain unsubstantiated. The problem is that even benign environmental elements can affect brain development in experimental systems because the building of well-functioning brain architecture is exquisitely sensitive to both genetic and environmental regulation. So, the field is left with basic findings that implicate a variety of genetic and epigenetic factors, together with associated small to modest increases in odds ratios for ASD due to a lengthening list of investigated environmental factors. (...)

Perhaps it is a coincidence that the odds ratio for ASD risk in the study by Croen and colleagues increases when first-trimester exposure to SSRIs is the sole factor. However, it is exactly that time of human brain development during which cortical and subcortical neuronal populations are being produced, migrating to their final destinations and beginning the long process of wiring. While much occurs later, the establishment of a strong foundation developmentally may be an essential component of healthy brain development. Croen and colleagues note more than once in their article that the study should not be taken as carte blanche for withholding SSRI treatment from pregnant mothers who are suffering the stress of depression and related disorders. Altered neurochemistry and stress response systems during pregnancy may affect the fetus as well. New basic neurobiology studies that focus on the importance of 5-HT in brain development and further advances in analyzing prospectively collected clinical data and outcomes will lead to a sound evidence-based approach to the clinical management of individuals who are suffering during a period that should be among the most joyous in their life. (...)

Is Autism, at Least in Part, a Disorder of Fetal Programming?
Arch Gen Psychiatry 2011 (Published online July 5)
The year 1977 marked an important milestone in the history of autism. In this year, the first twin study in autism was published by Folstein and Rutter¹; it demonstrated a striking difference in concordance rates between monozygous (MZ) and dyzgyous (DZ) twins. The studies that followed reported even higher MZ concordance rates, up to 90%, for a broader phenotype resembling what is currently labeled as autism spectrum disorder (ASD)^2-4 and DZ concordance rates at or close to 0%. This resulted in heritability estimates greater than 90%, suggesting that almost all of the variance in phenotypic expression could be attributed to inherited genetic factors.

There was an important need to revisit those early heritability estimates given that there have been significant improvements in the diagnosis of ASD and that the prevalence rates on which the original models were based are now much greater. In addition, the fact that the concordance for DZ twins was so close to 0% has always been a puzzling finding largely ascribed to the imprecision of the estimates. Family studies of nontwin siblings have suggested that the recurrence risk is closer to 5%, or even 10%, once stoppage rules are taken into account.⁵ Even so, based on these twin studies, ASD was often described as the most heritable of psychiatric disorders. It must be admitted, though, that the field has been frustrated by the difficulty in identifying the specific inherited genetic mechanisms for the etiology of ASD. Even the recent genome-wide association studies have not given us any smoking guns, and the top hits have been difficult to replicate. (...)

Firmaer skjuler negative medicinforsøg
ekstrabladet.dk 13.10.2010
Medicinalfirmaerne vildleder forbrugerne ved kun at offentliggøre de testresultater, som kommer positivt ud, advarer forskere (...)

Læger og patienter bliver ført bag lyset af medicinalfirmaerne, som skjuler negative resultater fra kliniske forsøg, så deres medicin fremstår mere effektiv end den er, advarer eksperter. (...)

Et tysk forskerhold har i det anerkendte tidsskrift British Medical Journal offentliggjort en gennemgang af ikke tidligere offentliggjorte forsøg med antidepressivet reboxetine (Edronax). De konkluderer, at medicinen ikke er blevet fremstillet i et sandfærdigt lys, skriver BBC.co.uk. (...)

'Vores fund understreger det tvingende behov for tvungen offelitggørelse af førsøgsdata' konkluderer undersøgelsens bagmænd ifølge BBC.co.uk. (...)

Undersøgelsen kommer i kølvandet på flere kritiske historier om medicinalindustrien: Medicinalgiganten Glaxo Smith Kline er ligesom Pfizer blevet anklaget for at tilbageholde kritiske resultater i forhold til diabetesmedicinen Avandia og antidepressivet Seroxat.

Tidligere på måneden blev medicinalfirmaerne i bogen 'Sex, lies and Pharmaceuticals' anklaget for at opfinde nye sygdomme og sygeliggøre raske, så de kunne sælge mere medicin. (...)

(Anm: Antidepressiva (nytteverdi) (mintankesmie.no).)

Public 'misled' by drug trial claims (Publikum "villedet" av påstander i legemiddelforsøk)
By Michelle Roberts Health reporter, BBC News
bbc.co.uk 13.10.2 010
Drugs need to undergo extensive testing in trials before approval

Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.
Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings. (...)

(Anm: Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ 2010; 341:c4737 (12 October).)

(Anm: reboxetine (Edronax) (felleskatalogen.no).)

Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials.
BMJ 2010; 341:c4737 (12 October)
Objectives To assess the benefits and harms of reboxetine versus placebo or selective serotonin reuptake inhibitors (SSRIs) in the acute treatment of depression, and to measure the impact of potential publication bias in trials of reboxetine.

Design Systematic review and meta-analysis including unpublished data. (...)

Conclusions Reboxetine is, overall, an ineffective and potentially harmful antidepressant. Published evidence is affected by publication bias, underlining the urgent need for mandatory publication of trial data. (...)

Table 4 Examples of publication bias and industry sponsorship bias in trials of antidepressants

In addition to publication bias, outcome reporting bias has been identified as a major problem in the reporting of clinical trials, resulting in a distorted public record of an intervention.^{35 36 37 38} Our review also identified this type of bias—for three reboxetine trials, only results on subpopulations or selected outcomes were available in the published literature (trials 047, 050, 052; table 1).

The more positive benefit-risk ratio in published data compared with unpublished data also affects the content of clinical guidelines. For example, the National Institute for Health and Clinical Excellence (NICE) guideline on the treatment and management of depression in adults is based on published studies of reboxetine, and concludes that “Reboxetine is superior to placebo and as effective as other antidepressants in the treatment of depression.”¹⁰ In our opinion, this conclusion can no longer be upheld.

The ongoing problem of publication bias shows that unbiased decision making in health care requires mandatory public disclosure of all clinical trial data. The US FDA Amendments Act of 2007³⁹ solves the problem in part by requiring protocol information and study results for clinical trials to be made public on the clinicaltrials.gov website (www.clinicaltrials.gov; please see accompanying comment (doi:10.1136/bmj.c4942) for further details). Similar legislation is also being introduced in Europe, with the mandatory public disclosure of data from the clinical trials database EudraCT (eudract.ema.europa.eu),^{40 41} but the date of implementation is not yet clear.

As the full assessment reports on reboxetine prepared by regulatory authorities are not publicly available, it is not clear as to how the comprehensive body of evidence (including that on efficacy outcomes) generated after reboxetine was approved in Europe in the late 1990s has been analysed by these authorities. The reason for the difference in approval status of reboxetine between Europe and the US thus remains unclear.(...)

Tvivl om antidepressiv medicin
videnskab.dk 21.9.2009
En kritisk artikel i det højt ansete, videnskabelige tidsskrift The New England Journal of Medicine har sat spørgsmålstegn ved effekten af 'lykkepiller'. (...)

Kun positive resultater publiceret
Faktisk var der nøjagtig lige mange undersøgelser med positive resultater (36), som med direkte negative resultater (24) samt tvivlsomme resultater (12), der hverken var klart positive eller negative med hensyn til en tydelig virkning af den antidepressive medicin. (...)

More Questions About Paxil Side Effects (Flere spørsmål om Seroxats (Paxils) sideeffekter)
lawyersandsettlements.com 29.5.2010
Chicago, IL: En ny artikkel i ScienceNews reiser spørsmål om risiko for Seroxats (Paxils) sideeffekter og fødselsdefekter hos barn eksponert for antidepressiva før fødselen. Artikkelen referer til studier som antyder udefinerbare forandringer i hjernene til babyer eksponert for antidepressiva av typen selektive serotoninreopptakshemmere (SSRIer). Seroxat (Paxil) er et av legemidlene i SSRI-klassen. (Chicago, IL: A new article in ScienceNews raises questions about the risk of Paxil side effects and Paxil birth defects in children exposed to the antidepressant prior to birth. The article cites studies that suggest subtle changes in the brains of babies exposed to Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants. Paxil is one of the drugs in the SSRI class.)

According to the author of the ScienceNews (06/05/10) article, Susan Gaidos, studies conducted in the past few years indicate that mice and rats exposed to antidepressants either just before or just after birth grew up anxious and depressed. A more recent study, according to Gaidos, suggests that children exposed to antidepressants while in the womb are more likely to appear sad or withdrawn at three years old than those not exposed to antidepressants.

Serotonin is produced naturally in the brain and is released into the spaces between the person's neurons. The neuron that releases the serotonin then takes it back almost immediately. This is called reuptake. Selective Serotonin Reuptake Inhibitors work by preventing serotonin's reuptake. The longer serotonin remains in the space between neurons (known as the synapse), the better the person feels. People who are depressed may feel less so because the serotonin remains in the synapse for longer. (...)

Psykiater dømt til drøyt 8 års fengsel for svindel bl.a. i Seroxat-forsøk

Maria Carmen Palazzo: Debarment Order (Maria Carmen Palazzo: Kjennelse om utelukkelse)
federalregister.gov 28.3.2011
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Maria Carmen Palazzo, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Palazzo was convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product or otherwise relating to the regulation of any drug product under the FD&C Act. Dr. Palazzo was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. (...)

FDA's finding that debarment is appropriate is based on the felony convictions referenced herein for conduct relating to the development or approval, including the process for development or approval, of any drug product and otherwise relating to the regulation of any drug product under the FD&C Act. The factual basis for those convictions is as follows: Dr. Palazzo was a licensed medical doctor with offices located in New Orleans, Louisiana. SmithKline Beecham, Corporation, d.b.a. GlaxoSmithKline (SKB) was a pharmaceutical company engaged in developing, testing, and marketing pharmaceutical products including Paroxetine, also known as “Paxil.” Under the FD&C Act and its implementing regulations, SKB had to apply to FDA for approval to market Paxil. SKB was required to demonstrate, through clinical investigations in which Paxil was given to human subjects, the safety and effectiveness of the drug in order to receive approval from FDA. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Paxil Researcher Pleads Guilty to Charges (Seroxat-forsker erklærer seg skyldig i anklager)
lawyersandsettlements.com 2.9.2010
Washington, DC: GlaxoSmithKline er gjenstand for mer dårlig publisitet etter at en forsker angivelig har forfalsket data i forsøk på Seroxat (Paxil). Samtidig er legemiddelfirmaet saksøkt grunnet påstander om at nyfødte er påført fødselsskader grunnet eksponering for Seroxat (Paxil) i svangerskapet. (Washington, DC: GlaxoSmithKline is the subject of more bad publicity after a researcher was allegedly found to have falsified data in trials about Paxil. Meanwhile, the drug maker faces lawsuits alleging newborns suffered Paxil Birth defects when they were exposed to Paxil prior to birth.)

The psychiatrist who reportedly falsified clinical data, Dr. Maria Carmen Palazzo, was a clinical investigator on studies conducted by SmithKline Beecham (doing business as GlaxoSmithKline). According to CNBC on 8/20/10, Palazzo has now pleaded guilty to 15 counts of failing to prepare and maintain records with the intent to defraud and mislead.

Palazzo reportedly included children in a study that involved diagnoses the children did not have. Prosecutors claimed that Palazzo also reported symptoms that her study subjects did not exhibit. She was sentenced to 13 months in prison, which she is serving at the same time as an 87-month term for healthcare fraud.

Ifølge BNET (08/19/10) ble Palazzo anklaget av den amerikanske legemiddelkontrollen FDA (Federal Drug Administration) for hennes innrullering av barn i studier med tvangslidelser (OCD) og tyngre depressive lidelser til tross for at barna hun undersøkte ikke hadde en egnet diagnose for inkludering i studien. (According to BNET (08/19/10), Palazzo was charged after the Federal Drug Administration (FDA) accused her of enrolling children in studies of obsessive-compulsive disorder and major depressive disorder even though the children she studied did not have the proper diagnosis for inclusion in the study.)

Paxil now carries a black box warning about the risk of suicide in children. It also carries a warning about the risk of birth defects in babies exposed to the antidepressant prior to birth. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Jailed psychiatrist pleads guilty (Fengslet psykiater erkjenner seg straffeskyldig)
cnbc.com 20.8.2010
NEW ORLEANS – En 58 år gammel psykiater involvert i to kliniske forsøk som evaluerte legemidlet Seroxats (Paxils) sikkerhet og effekt hos barn og ungdommer har i forbindelse med disse kliniske forsøk erkjent seg straffeskyldig på 15 statlige tiltalepunkter for manglende utarbeidelse og oppfølging av protokoller, med den hensikt å bedra og villede. (NEW ORLEANS - A 58-year-old psychiatrist involved in two clinical trials evaluating the drug Paxil's safety and effectiveness in children and adolescents has pleaded guilty to 15 federal counts of failing to prepare and maintain records, with intent to defraud and mislead, in connection with those clinical trials.)

Dr. Maria Carmen Palazzo var klinisk forsker hos SmithKline Beecham som utførte arbeider under GlaxoSmithKline. Aktorene sa at hun i løpet av disse studier inkluderte psykiatriske diagnose uten overensstemmelse med pasienters psykiatriske historier; utarbeidet atskillige psykiatriske evalueringer på studiedeltakere som inneholdt forskjellige diagnoser og rapporterte symptomer hun visste studiedeltakerne ikke hadde. (Dr. Maria Carmen Palazzo was a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline. Prosecutors say that during those studies she included psychiatric diagnoses inconsistent with patients' psychiatric histories; prepared multiple psychiatric evaluations on study patients which contained different diagnoses and reported symptoms she knew the study subject did not demonstrate.)

Hennes tilståelse kom torsdag for den amerikanske distriktsdommeren Mary Ann Vial Lemmon, som dømte henne til 13 måneders fengsel. Denne tiden løper samtidig som hun soner en fengselsdom på 87-måneders for svindel innen helsevesenet. (...) (She entered the plea Thursday before U.S. District Judge Mary Ann Vial Lemmon, who sentenced her to 13 months in prison. That term will run at the same time as her current 87-month prison term for health care fraud.)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: Uredelighet og fusk i medisinsk forskning. (mintankesmie.no/).)

JAILED PSYCHIATRIST PLEADS GUILTY AND IS SENTENCED ON CHARGES OF FALSIFIED RECORDS OF CLINICAL TRIALS INVOLVING CHILDREN (FENGSLET PSYKIATER ERKLÆRER SEG SKYLDIG OG ER DØMT FOR ANKLAGER OM FORFALSKNING AV JOURNALER FOR KLINISKE FORSØK SOM INVOLVERER BARN)
justice.gov 19.8.2010
DR. MARIA CARMEN PALAZZO, age 58, pled guilty in federal court today before U. S. District Judge Mary Ann Vial Lemmon to fifteen (15) counts of failing to prepare and maintain records, with intent to defraud and mislead, in connection with clinical trials to evaluate the efficacy and safety of Paxil in children and adolescents with Obsessive-Compulsive Disorder (OCD), announced U. S. Attorney Jim Letten.

According to court documents, PALAZZO, who specialized in psychiatry, was a clinical investigator for SmithKline Beecham d/b/a GlaxoSmithKline, was involved in two clinical trials evaluating Paxil’s safety and effectiveness in children and adolescents. Some of the study records indicated that PALAZZO included psychiatric diagnoses inconsistent with patients’ psychiatric histories; prepared multiple psychiatric evaluations on study patients which contained different diagnoses and treatment plans; reported symptoms of OCD when PALAZZO knew that the study subject did not demonstrate such symptoms; and reported that PALAZZO examined study subjects when she had not.

PALAZZO is currently serving an 87 month prison sentence after being convicted of 39 counts of health care fraud following a 12-day trial in April 2008. In the instant case, PALAZZO was sentenced to thirteen (13) months in prison to run concurrent to the previous sentence as well as serve one (1) year of supervised release during which time she will be under federal supervision and risk additional imprisonment should she violate any rulesof the release. Additionally, PALAZZO was ordered to pay restitution to GlaxoSmithKline in the amount of $91,824 and $1,500 in special assessments.

The case was investigated by the Food and Drug Administration’s Office of Criminal Investigations, U. S. Department of Health and Human Services, Office of Inspector General, the Federal Bureau of Investigation and the Louisiana Medicaid Fraud Control Unit.

The case was prosecuted by Assistant U. S. Attorney Patrice Harris Sullivan, the Health Care Fraud Coordinator in this District.

(Download Factual Basis) (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

10 Years Later, Glaxo Still Haunted by Faked Studies of Paxil in Kids (Glaxo 10 år senere fortsatt hjemsøkt av forfalskede studier på Seroxat hos barn)
bnet.com 19.8.2010
A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison. (...) (A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Psychiatrist indicted for fraud in Paxil trials (Psykiater anklaget for svindel i Seroxat-forsøk)
dailycomet.com 14.6.2007
NEW ORLEANS Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday. (...)

According to the indictment, Palazzo, as a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for evaluation the drug's safety and effectiveness in children and adolescents.

If convicted, Palazzo faces a maximum term of 445 years, and a fine of $10.15 million, Letten's office said. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Advarsler

January 2009 Safety Labeling Changes (Januar 2009 sikkerhetsendringer pakningsvedlegg (Seroxat (Paxil), Celexa, Cipramil, Zoloft, Cybalta, Efexor, Prozac, Venlafaxine, Pristiq etc.))
fda.gov 6.3.2009
- Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. (Posted 03/06/2009) (…)

WARNINGS
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions

WARNINGS
The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Celexa treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists (...)

(Anm: Serotonin syndrom (SS), kramper, parkinsonisme osv. (forhøyet kroppstemperatur) (mintankesmie.no).)

Antidepressiva kan øke kvinners risiko for hjerneslag

Antidepressants May Raise Women's Stroke Risk (Antidepressiva kan øke kvinners risiko for hjerneslag)
minorityhealth.hhs.gov 14.12.2009
(…) It found that women on selective serotonin uptake inhibitors (SSRIs, which include Celexa, Paxil, Prozac and Zoloft) had a 45 percent increase in risk for stroke and a 32 percent increase in risk for death from any cause, compared to non-users. Similar results were found for women on tricyclic antidepressants. (…)

Antidepressant Use and Risk of Incident Cardiovascular Morbidity and Mortality Among Postmenopausal Women in the Women's Health Initiative Study
Arch Intern Med. 2009;169(22):2128-2139 (Dec 14/28)
(...) Background Antidepressants are commonly prescribed medications, but their effect on cardiovascular morbidity and mortality remains unclear. (...)

Conclusions In postmenopausal women, there were no significant differences between SSRI and TCA use in risk of CHD, stroke, or mortality. Antidepressants were not associated with risk of CHD. Tricyclic antidepressants and SSRIs may be associated with increased risk of mortality, and SSRIs with increased risk of hemorrhagic and fatal stroke, although absolute event risks are low. These findings must be weighed against quality of life and established risks of cardiovascular disease and mortality associated with untreated depression. (...)

Immune cells cause more post-stroke brain damage: study (Immunceller forårsaker ytterligere hjerneskade etter slag, ifølge studie)
reuters.com 2.8.2009
HONG KONG (Reuters) - Scientists have identified a class of immune cells that floods the brain soon after a stroke, causing inflammation and more neurological damage.

In an experiment, Japanese researchers showed how mice that were deficient in these immune cells suffered far less brain damage after a stroke compared to normal mice.

The lead author of the study, Akihiko Yoshimura at Keio University's School of Medicine in Tokyo, explained that while the initial damage from a stroke cannot be prevented, drugs can be used to limit secondary damage caused by immune cells that rush to the site of the infarction, or stroke.

"The first damage happens immediately after a stroke, we can't block this because it is very rapid," Yoshimura said. (...)

Stroke May Trigger Memory Trouble
healthfinder.gov 10.4.2006
Decline can happen in the absence of other cognitive problems, such as dementia, researchers note

-- Stroke may harm memory without necessarily causing dementia or other cognitive impairment, researchers report.

Columbia University researchers in New York performed an initial assessment of nearly 1,300 people, averaging just over 76 years of age, with no cognitive impairment or dementia. The evaluations were done between January 1992 and December 1994, and the study volunteers were then re-examined at 18-month intervals until November 1999. (...)

Kalde arkivbevis - Seroxatrelaterte fødselsdefekter

2010 a Year for Paxil Birth Defects Plaintiffs to Remember (2010 et år å huske for saksøkere av fødseldefekter forårsaket av Seroxat)
lawyersandsettlements.com 25.12.2010
Dallas, TX: Plaintiffs who filed lawsuits alleging Paxil side effects such as Paxil birth defects and PPHN (persistent pulmonary hypertension of the newborn) may look back on 2010 as a year to remember. Hundreds of Paxil lawsuits were reportedly settled and a million-dollar award handed out in at least one other lawsuit. For plaintiffs who still have Paxil lawsuits pending, 2010 might be a year that provides them with hope that they will receive either a settlement or an award. (...)

Hundreds of Paxil Birth Defect Cases Reported Settled (Hundrevis av fødselsdefekt-saker for Seroxat (Paxil) rapportert forliket)
1888pressrelease.com 30.6.2010
New York, NY (1888PressRelease) June 30, 2010 - An order signed on June 15, 2010 by Justice Sandra Moss, has paved the way for the settlement of of hundreds of Paxil birth defect cases pending against GlaxoSmithKline, GSK. No Paxil birth defect cases have been tried since the October 13, 2009, verdict where a jury awarded $2.5M to the family of Lyam Kilker, a child born with a congenital heart defect caused by Paxil use during pregnancy.

Approximately 600 cases have been filed against GSK, most in the Mass Tort Program in the Court of Common Pleas in Philadelphia. It has been reported by the Legal Intelligencer that Judge Moss, the coordinating judge of Philadelphia's mass tort program, the Complex Litigation Center, said the philosophy of GSK "is to try and settle what they can and to settle in groups." (...)

The most common injuries caused by Paxil are (De mest vanlige skader forårsaket av seroxat (Paxil)):

Heart Birth Defects (Pulmonary Stenosis, Pulmonary Atresia, Atrial or Ventricular Septal Defects, Murmurs, etc)
Lung Birth Defects (Persistent Pulmonary Hypertension)
Craniosynostosis (resulting in an abnormally shaped head)
Abdominal Birth Defects (Omphalocele)
Cranial Birth Defects (Craniosynostosis)

If you or someone you know had a child who was born with a congenital heart defect or other birth defect, and the child was exposed to Paxil (paroxetine) during pregnancy, they may be entitled to significant compensation. For more information go to www.DrugSettlement.com. (...)

Use of antidepressants during pregnancy and the risk of spontaneous abortion (Bruk av antidepressiva under svangerskapet og risiko for spontanabort)
CMAJ 2010; 182 (10) (July 13)
(...) Interpretation: The use of antidepressants, especially paroxetine, venlafaxine or the combined use of different classes of antidepressants, during pregnancy was associated with an increased risk of spontaneous abortion. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Plaintiffs Hoping for More Paxil Birth Defects Settlements (Saksøker håper på flere flere forlik i saker om fødselsdefekter utløst av Seroxat (Paxil))
lawyersandsettlements.com 5.7.2010
Boston, MA: Although very little information has been released concerning the settlement of Paxil birth defects lawsuits, news reports indicate that approximately 190 cases have been settled while another 100 are in various stages of settlement.

At issue in the lawsuits is whether or not Paxil caused the birth defects of infants whose mothers took the antidepressant while pregnant. Scientific studies concerning the link between Paxil and other selective serotonin reuptake inhibitors (SSRIs) to birth defects have returned mixed results. Further studies have suggested a link between SSRIs and behavioral problems, withdrawal symptoms and developmental delays.

GlaxoSmithKline, however, has defended its drug and its own actions regarding Paxil. A spokeswoman for GlaxoSmithKline, Sarah Alspach, said in an e-mail statement that the company agreed to settle to avoid the costs and uncertainties of ongoing litigation

"GSK believes it acted properly and responsibly in conducting its clinical trial program for Paxil, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine's label as new information became available," Alspach wrote, as published in the Legal Intelligencer on 6/23/10.

Plaintiffs, however, disagree. They argue that GlaxoSmithKline failed to adequately warn physicians and patients about the risks of birth defects when babies are exposed to Paxil prior to birth. They allege those birth defects include Persistent Pulmonary Hypertension of the Newborn (PPHN) and atrial or septal defects—holes in the heart. (...)

Scores of Paxil Birth Defects Cases Settled (Inngår forlik i saker som omhandler Seroxat (Paxil)-relaterte fødselsdefekter)
consumeraffairs.com 24.6.2010
Terms of agreements kept confidential

The manufacturer of Paxil has agreed to settlements in nearly 200 individual cases claiming that the antidepressant caused birth defects.

Most of the cases allege that babies born to mothers taking Paxil suffered from heart defects. The leading case, brought on behalf of Lyam Kilker, contended that he was born with no fewer than three cardiac defects, including a hole between the two chambers of his heart that disrupted the aorta. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Common antidepressants 'increase miscarriage risk' (Vanlige antidepressiva "øker risiko for abort")
telegraph.co.uk 1.6.2010
Taking common antidepressants while pregnant significantly increases the chances of suffering a miscarriage, a new study warns.

The risk rose by more than two thirds if expectant mothers were taking the drugs, researchers found.

Previous studies have also found a link between antidepressants and birth defects.(...)

Dr. Anick Berard, from the University of Montreal, who led the research, said: "These results, which suggest an overall class effect of selective serotonin re-uptake inhibitors, are highly robust given the large number of users studied.

They found an increased risk associated with SSRIs, especially Seroxat (also called paroxetine) and Efexor (also called venlafaxine). (...)

Overall, the increased risk was 68 per cent. (...)

Antidepressants Associated With Miscarriage Researchers find antidepressant use during pregnancy may increase risk of spontaneous abortion
modernmedicine.com 1.6.2010
TUESDAY, June 1 (HealthDay News) -- Use of antidepressants during pregnancy, particularly paroxetine, venlafaxine, or a combination of different antidepressant classes, may increase the risk of miscarriage by 68 percent, according to research published online May 31 in CMAJ, the journal of the Canadian Medical Association. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: Use of antidepressants during pregnancy and the risk of spontaneous abortion. CMAJ 2010 (Published online ahead of print May 31, 2010).)

Cold Case Files - Paxil Birth Defects (Kalde arkivbevis - Seroxatrelaterte fødselsdefekter)
by Evelyn Pringle
scoop.co.nz 2.3.2010
Almost like an episode of the TV show, Cold Case Files, the first Paxil birth defect trial was dominated by a story about what happened to the rat pups that died around 1979 and1980, involved in a study in which Paxil was being tested on pregnant female rats. (...)

The family's lead attorney in the case of Kilker v Glaxo, Sean Tracey from Houston, brought in the world-famous neuropsychopharmocology expert from Wales, Dr David Healy, to testify extensively about rat pup study 295.

In summary, Healy told the jury that all the rat pups born to mothers who received Paxil were dead four days after they were born, while eighty-eight percent of the pups not exposed to Paxil were still alive on day four.

In fact, of the 415 rat pups born to mothers who received Paxil, Healy testified that, “One in every ten or actually maybe more like possibly one in every eight or so were born dead.”

As far as he could make make out, all the rats were not autopsied, Healy said, so the question was why the pups died.

“It's clearly the drug that has caused the death,” he told the jury.

“One of the possible reasons for their death is they're born with birth defects that lead to them actually dying early in infant life,” he testified. “A responsible approach to data like this is to investigate it further and find out just what the cause is.”

Doctor Suzanne Parisian, a former FDA scientist, also served as an expert for the plaintiffs. She testified that the first safety signals that indicated Paxil could cause birth defects were seen in the animal studies conducted in 1979-1981 period, as well.

Parisian said the studies showed birth defects, embryos that died, and rat pups that did not survive.

Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony. While testifying, Peavy had Parisian review comments in a memo by a Doctor John Baldwin to Glaxo in 1980, discussing the Ferrosan studies, which stated: “There remains the possibility that this compound could be teratogenic at high-dose levels.”

“We need to ascertain whether Ferrosan have conducted or are conducting or intend to conduct a peri- and postnatal study and a neonatal acute toxicity study,” Baldwin wrote.

Based on her review the documents, Parisian told the jury, Glaxo never ascertained whether Ferrosan did the studies and Glaxo never conducted the studies.

As far as she knew, the company never told the FDA about Baldwin's statements either, she said, but “they should have.” (...)

Spontanaborter er nå listet blandt Seroxats sideeffekter

Miscarriage Now Listed Among Paxil Side Effects (Spontanaborter er nå listet blandt Seroxats (Paxils) sideeffekter)
lawyersandsettlements.com 6.6.2010
Montreal, Quebec: While the risks involved in the use of selective serotonin reuptake inhibitor antidepressants among pregnant women have been well documented, a new study is adding miscarriage to the list of potential Paxil side effects.

The study, performed by researchers at the Universite de Montreal, followed a number of expectant mothers who had been prescribed antidepressants throughout their pregnancy. The researchers found that the usage of SSRIs, in particular paroxetine (Paxil) and venlafaxine (Effexor), led to a 68 percent increase in the risk of miscarriage.

The general risk of miscarriage for women is only 20 percent, but according to the study's head researcher, Dr. Anick Berard, the medications can push the risk up to 34 percent. (...)

Storbritannia krever alle SSRI-data

U.K. demands all SSRI data (Storbritannia krever alle SSRI-data)
FIERCEPHARMA.COM 3.3.2008
NICE, you'll recall, is reviewing its guidelines for the use of SSRI drugs, aiming to issue new treatment advice this fall. Failing to hand over that data "would leave the inevitable impression they had something to hide," the minister said. In the past, another official said, the government has been unable to get access to unpublished trials.

The request comes on the heels of last week's study showing that SSRIs were effective only in the most severely depressed patients. Despite the U.K.'s official position that drugs shouldn't be the first line of defense against depression, they're among Britain's most prescribed meds with more than 31 million scrips in 2006. (...)

Drug firms pressed on secret pill data (Legemiddelfirmaer presset på hemmelige pilledata)
guardian.co.uk 2.3.2008
The big pharmaceutical companies are to be 'shamed' into handing over their secret data on the effects of antidepressant medications, amid growing concern that the 'sunshine pills' may not work as well as originally promised.

A government minister has taken the unprecedented step of calling on the drugs companies to give the data to the body that will review the current depression guidelines, the National Institute for Health and Clinical Excellence (Nice). Ivan Lewis, the minister with responsibility for mental health, said that 'a failure to do so would leave the inevitable impression they had something to hide'. (...)

Backed by the government, Nice is now set publicly to ask for all the data, which would leave the companies facing huge criticism if they did not hand it over. The toughening stance towards the companies follows the publication last week of a major review that examined all available data on the drugs, including trials that had not been published. (...)

Innrapporterte legemiddelreaksjoner tredoblet i USA

U.S. Reports of Drug Reactions Triple (Innrapporterte legemiddelreaksjoner tredoblet i USA)
ap.google.com 11.9.2007
CHICAGO (AP) — Rapporter om alvorlige sideeffekter og dødsfall grunnet legemidler ble ifølge en analyse av amerikanske data nesten tredoblet i perioden 1998 til 2005. (CHICAGO (AP) — Reports of dangerous side effects and deaths from widely used medicines almost tripled between 1998 and 2005, an analysis of U.S. drug data found.)

Antallet innrapporterte dødsfall og alvorlige skader grunnet reseptbelagte legemidler og ikke-reseptbelagte legemidler til Food and Drug Administration i studieperioden økte fra 34 966 til 89 842. (...) (The number of deaths and serious injuries from prescription and over-the-counter drugs climbed from 34,966 to 89,842 during the study of reports to the Food and Drug Administration.)

Legemidler hyppigst linket til alvorlige ikke-dødelige komplikasjoner, inkludert insulin, er artritislegemidlene Vioxx og Remicade, og antidepressivaet Seroxat (Paxil). (Drugs frequently linked with serious nonfatal complications included insulin, the arthritis drugs Vioxx and Remicade, and the antidepressant Paxil.)

(Anm: Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005. Arch Intern Med. 2007;167(16):1752-1759. (10.9.2007).)

- Här får du ett medel och dina personlighetsdrag kommer att förändras

Medicin ändrar personligheten
sr.se 8.12.2009
En typ av antidepressiva medel, så kallade SSRI preparat, ger en personlighetsförändring. Det handlar om minskad ängslighet. Det visar en mindre amerikansk studie på totalt 240 personer. (...)

Elias Eriksson som är professor i farmakologi vid i Göteborg. Han menar att problemet är att SSRI preparat först lanserades som antidepressiva läkemedel, även om de inte har störst effekt där. De ska absolut inte ska användas för personer som är ledsna:

– Om man är ledsen av yttre orsaker bör man inte äta sådant här. Det tror jag är ett av de vanligaste felen till överförskrivning, det är att man skriver ut det här till personer som varken har någon depressions sjukdom eller något ångesttillstånd utan som har en nedstämdhet orsakad av yttre omständigheter. Då ska man inte förskriva de här medlen. Däremot vid depression eller ångettillstånd bör de användas.

Men kan du förstå då om det kan låta obehagligt för personer att höra "här får du ett medel och dina personlighetsdrag kommer att förändras"? (...)

(Anm: Personality Change During Depression Treatment. Arch Gen Psychiatry. 2009;66(12):1322-1330 (December).)

(Anm: personlighetsendring; varig endring i en persons måte å tenke, reagere og være på i personlige og sosiale situasjoner (jfr. personlighet). (…)

Årsaker - Personlighetsendring kan være forårsaket av legemlige sykdommer eller skader som rammer hjernen (bl.a. organisk betingede psykiske lidelser som f.eks. demens), skyldes langvarig misbruk av stoff eller andre rusmidler (f.eks. alkohol), eller forekomme som en del av utviklingen av en alvorlig psykisk lidelse som f.eks. schizofreni. Tilstander som kan minne om varig personlighetsendring, finnes også hos psykologisk sett selvusikre, søkende individer som på jakt etter klare verdier og med behov for å tilhøre et fellesskap trekkes inn i enkelte ekstreme religiøse bevegelser. Kilde: Store norske leksikon.)

(Anm: SSRI-utløst aggresjon? (mintankesmie.no).)

Antidepressiva kan endre din personlighet
nrk.no 7.12.2009
Ifølge en studie utført på vegne av det amerikanske helsevesenet kan medisiner med virkestoffet Paroxetine gjøre folk både mindre nevrotiske og mer utadvendte, skriver Reuters.

Paroxetine finnes i blant annet Paroxat, Paroxetin og Seroxat, som selges som reseptbelagte midler i Norge. (...)

- Det er en dramatisk forskjell, sier Tang, og forklarer at man tidligere har trodd at endring i personligheten kom fordi man fikk depresjonen mer under kontroll. (...)

www.paxilpayback.org

Public Citizen launched www.paxilpayback.org as a public service Did your child take Paxil? Get a refund. (www.paxilpayback.org)
http://www.citizen.org/

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Sterk link funnet mellom to antidepressiva og spedbarns hjerteproblemer

Strong Link Found Between Two Antidepressants and Infant Heart Problems (Sterk link funnet mellom to antidepressiva og spedbarns hjerteproblemer)
depression.about.com 25.11.2008
Women who took the antidepressants Prozac (fluoxetine) or Paxil (paroxetine) in their first trimester were significantly more likely to give birth to babies with heart problems than women who did not take them, according to a new study published in the November issue of the British Journal of Clinical Pharmacology. (...)

(Anm: British Journal of Clinical Pharmacology. Paroxetine and fluoxetine in pregnancy: a prospective, multicentre, controlled, observational study 2008;66: 695-705.)

Legger antidepressiva en demper på kjærlighetslivet?

Sexgale ældre bliver kastreret med lykkepiller
bt.dk 9.3.2008
Gamle kan være så demente, at de mister hæmningerne og får ustyrlig lyst til sex. Lægerne giver dem lykkepiller og anden medicin, som kan lægge låg på lysterne. (...)

(Anm: Effect of citalopram in treating hypersexuality in an Alzheimer's Disease case. Neurol Sci. 2008 Sep;29(4):269-70. Epub 2008 Sep 20.)

Dette dreper de unges sexlyst
dinside.no 5.5.2008
Hasj kan ødelegge sexlysten for unge.

Det er én ting som tar knekken på selv tenåringenes potens. (...)

- Mange som bruker hasj, blir sløve, tiltaksløse og får ikke hverdagen til å fungere, verken med jobb eller skole. Mange får etter hvert nedbrutt selvbilde, noe som kan resultere i depresjon og angst. At de som går på antidepressiva, også kan få potensproblemer, er noe vi kjenner til. Men dette er problemer som først kommer frem etter noen ganger med behandling, sier han. (...)

Are antidepressants taking the edge off love? (Legger antidepressiva en demper på kjærlighetslivet?)
latimes.com 30.7.2007
Sure, we know about the sexual side effects of SSRIs. But researchers now wonder if that's the only aspect of romance the drugs can influence. (...)

Any drug that has sexual side effects, Thomson says, could well blunt other chemicals the brain uses to intently focus on one person or to work up the obsession necessary to fall in love in the first place.

Then there was the 42-year-old single woman who had not been on a date in the eight years she had been taking an antidepressant. "She had not felt any desire [to date] for at least that period of time," he says. (...)

At that time, reports were that only about 6% of patients suffered sexual side effects, but the low rate is now understood to have resulted because doctors failed to ask questions about sex and patients were reluctant to bring it up. A later analysis put that figure at about 30%, and a 2001 study at as high as 73%. It is one of the top reasons that people stop taking the drugs. (...)

(Anm: Love is blue. (magicvalley.com 13.8.2007).)

5 Questions for 'Doctor of Love' Researcher Helen Fisher
popularmechanics.com 13.2.2008
(...) Are there certain advancements in, say, new drugs or antidepressants that can have an adverse on this quest you’re speaking about?
Yes. I think we’ve evolved through distinctly different brain systems involved for mating and reproducing. One is the sex drive, one is romantic love, and the third is attachment—that sends the sense of calm and security you can feel with a long-term partner. And when you take the serotonin-enhancing antidepressants like Prozac, Paxil, Zoloft, etc., what you’re doing is driving up serotonin in the brain, and we know that that affects the sex drive. In almost 75 percent of people it kills the sex drive. (...)

Paedophiles offered 'happy pills' to curb their sex drive (Pedofile tilbudt "lykkepiller" for å dempe sexlyst)
dailymail.co.uk 14.11.2007
Det er kommet frem at pedofile tilbys gratis Prozac som alternativ til "kjemisk kastraksjon". (Paedophiles are to be offered free Prozac as a softer alternative to 'chemical castration', it has emerged.)

The Government secured headlines this summer when it promised offenders would be given - on a voluntary basis - strong medication to curb their sex drive.

However, these drugs, which amount to chemical castration by making it difficult to have sex, have a number of side-effects which could deter potential users. (...)

Brain Chemical Could Spur Lovesickness
healthfinder.gov 15.10.2008
A monogamous rodent could shed light on romantic loss. (...)

Examination of the brains of the lovesick voles revealed heightened activity of a chemical messenger called corticotropin releasing factor (CRF) in an area of the hypothalamus, a center for emotions in the brain.

When the researchers administered a drug that blocked CRF activity, voles who'd been separated from their mate began to perform just as vigorously in the stress tests as all the other voles tested. It seemed the drug "switched off" the mechanism -- and their lovesickness, as well. (...)

(Anm: Pharmacologic differences among the SSRIs: focus on monoamine transporters and the HPA axis. CNS Spectr. 2004 Jun;9(6 Suppl 4):23-31.)

Antidepressiva kan skade menns fruktbarhet (DNA), ifølge studie

Antidepressants may damage male fertility: study (Antidepressiva kan skade menns fruktbarhet, ifølge studie)
reuters.com 24.9.2008
LONDON (Reuters) - Common antidepressant drugs may reduce some men's fertility by damaging the DNA in their sperm, according to scientists.

A study of 35 healthy men given paroxetine -- sold as Paxil or Seroxat by GlaxoSmithKline -- found that, on average, the proportion of sperm cells with fragmented DNA rose from 13.8 percent before treatment to 30.3 percent after just four weeks.

Similar levels of sperm DNA damage have been linked to problems with embryo viability in couples trying to have children. (...)

Allan Pacey, Senior Lecturer in Andrology at the University of Sheffield, said the apparent increase in sperm DNA damage was "alarming," although he noted the level at which damage becomes clinically significant was open to debate. (...)

Anti-Depressant-Associated Changes In Semen Parameters
medpagetoday.com 28.11.2008
SAN FRANCISCO, CA, USA (UroToday.com) - The authors previously reported an effect of antidepressants on semen parameters. The current study was designed to assess/confirm their prior report of the effects of an SSRI, paroxetine (Paxil), on semen parameters. (...)

As opposed to prior report, semen parameters (volume, concentration, motility, morphology) were not significantly altered during SSRI treatment. However, mean DNA fragmentation TUNEL score was significantly higher on SSRI (30.3%) versus baseline (13.8%). Multivariate logistic regression, correcting for age and body mass index, confirmed that SSRI treatment was significantly correlated with increased DNA fragmentation Up to 35% of men noted significant changes in erectile function and up to 47% of subjects reported ejaculatory difficulties while on paroxetine. (...)

Antidepressants may reduce male fertility (Antidepressiva kan redusere menns fruktbarhet)
endocrinetoday.com 18.11.2008
ASRM 64th Annual Meeting
Treatment with paroxetine was associated with increased DNA fragmentation in sperm, according to study results presented at the American Society for Reproductive Medicine 64th Annual Meeting in San Francisco.

“In volunteer male patients with normal semen parameters, paroxetine induced abnormal sperm DNA fragmentation in a significant proportion of patients. … The fertility potential of a substantial proportion of men on paroxetine may be adversely affected by these changes in sperm DNA integrity,” wrote the researchers from Massachusetts General Hospital and Weill Medical College of Cornell University.

They enrolled 35 healthy men aged 18 to 65 years in the prospective clinical trial. Volunteers were assigned daily paroxetine for five weeks in varying doses: week one, 10 mg; week two, 20 mg; weeks three and four, 30 mg; and week five, 20 mg. The researchers analyzed semen at baseline, weeks two and four and one month after treatment with paroxetine was stopped.

Treatment with paroxetine increased the mean DNA fragmentation score from 13.8% at baseline to 30.3% (P=.0002). Before starting treatment with paroxetine, 9.7% of men had a fragmentation score ≥30% compared with 50% of men at week four (P=.001).

The drug was associated with an OR of 9.33 (95% CI, 2.3-37.9) for abnormal DNA fragmentation, which persisted after adjustment for age and BMI (P=.0003).

Up to 35% of men reported significant changes in erectile function and up to 47% reported ejaculatory problems while receiving paroxetine, according to volunteer responses from the Brief Sexual Function Inventory. However, partial recovery of sexual function was observed one month after cessation of paroxetine. (...)

Antidepressants 'Could Damage Sperm' (Antidepressiva "kan skade sædceller")
cbs4denver.com 26.9.2008
(CBS4) Antidepressants could be damaging men's sperm and their chances of fathering a baby, new research suggests.

Fertility experts said new evidence that some anti-depression drugs may cause fragmentation of the sperm DNA could help explain why so many couples are struggling to conceive. (...)

Father Wonders if Paxil caused Two Holes in Daughter's Heart (Far undrer på om Seroxat forårsaket to hull i datterens hjerte)
lawyersandsettlements.com 11.11.2008
Lebanon, IN: Mark's daughter was born with two holes in her heart. Although his wife was not taking Paxil during her pregnancy, he was. He wonders if the heart defects, which match the Paxil-related birth defects, may be related to his use of the antidepressant. He can find no other plausible explanation.

Mark has depression, and his doctor prescribed the selective serotonin receptor inhibitor (SSRI) Paxil, also called paroxetine, in the hope that it would help. Mark had been taking the drug for about 3 months when his wife became pregnant. "I started taking Paxil around April 2005, and our daughter was conceived in August," Mark said. (...)

Svårare bli pappa med antidepressiva
sr.se 26.9.2008
(...) Antidepressiva läkemedel kan göra det svårare för män att få barn. Det tycks bero på att spermierna drabbas av skador i sitt DNA, visar en första, mindre undersökning från Cornell Medical Centre i New York. (...)

Paxil could make men infertile, researchers suggest
pharmatimes.com 25.9.2008
US scientists have claimed that one of the most commonly used selective serotonin re-uptake inhibitors, GlaxoSmithKline's Seroxat/Paxil, causes serious DNA damage in sperm cells, according to the report in New Scientist. (...)

- Uten oksygen vil dens elastiske fibre omdannes til bindevev...

- Frist den eller mist den
vg.no 5.10.2008
Advarsel: Menn kan miste muligheten til å få ereksjon hvis de går lenge uten sex. (...)

Normalt sett har menn i gjennomsnitt tre ereksjoner i søvne per natt, hvilket er nok til å opprettholde reisningsfunksjonen.

Men dersom du for eksempel går på sovemedisin, hjertemedisin eller tar antidepressive midler, forsvinner nattlige ereksjoner.

Søvnen blir ikke dyp nok, ifølge Mortensen. Det samme gjelder prostataopererte, nevrologisk syke, rusavhengige og menn med diabetes. (...)

- Du kan få penis til å virke igjen ved å pumpe den opp med vakuumpumpe tre ganger i uken, men dette er en møysommelig prosess.

- Går i dvale
Penis består av delikate svamplegemer som trenger oksygentilførsel. Det fås gjennom ereksjon. Uten oksygen vil dens elastiske fibre omdannes til bindevev, ifølge Purvis.

- Bindevevet gjør penis slapp. Du kan sammenligne det med et punktert bildekk, sier Purvis. (...)

- Antidepressiva kan fremkalle eller forsterke seksuell dysfunksjon

Seksuelle bivirkninger av antidepressive legemidler
Tidsskr Nor Legeforen 2010; 130:1930-1 (7.10.2010)
Seksuell dysfunksjon er vanlig hos pasienter med depresjon. Samtidig kan antidepressive legemidler fremkalle eller forsterke seksuell dysfunksjon som bivirkning. Hvilke antidepressiver er særlig assosiert med seksuell dysfunksjon, og hvilke mekanismer ligger til grunn for slike bivirkninger? Hvordan skal bivirkningene håndteres i klinisk praksis? (...)

Forekomst
Alt i alt er forekomsten av seksuelle bivirkninger anslagsvis 40 % ved bruk av SSRI-preparater, mot 10 % ved placebo (2). Det finnes få studier som har sammenliknet frekvensen av seksuelle bivirkninger hos ulike SSRI-preparater. En gjennomgang fra 2008 konkluderte med at det ikke foreligger sikre holdepunkter for at noe SSRI-preparat har færre seksuelle bivirkninger enn andre, selv om det finnes visse data som antyder at slike bivirkninger er vanligere ved paroksetin enn ved andre midler i gruppen (4). (...)

Antidepressants may damage more sex lives (Antidepressiva kan skade mange menneskers sexliv)
boston.com 15.12.2008
Sexual "numbness." Lack of libido. Arousal that stalls. (...)

Current warnings on the labels of selective serotonin reuptake inhibitors, or SSRIs, cite early studies in which the prevalence of sexual side effects was lower: 4 percent for Prozac, for example, and ranging from 0 to 28 percent for Paxil.

But more recent studies, in which patients were more likely to be asked about specific sexual side effects and thus more likely to report them, suggest that the ballpark range of those affected by SSRIs is between 30 percent and 50 percent, said researchers including Dr. Richard Balon, a psychiatry professor at Wayne State University who studies the symptoms.

That would translate into millions of affected sex lives among the estimated 1 in 8 American adults who have tried these antidepressants in the past decade or so. Some studies have found the range still higher. (...)

Balon and other researchers agree that the issue is complex and the science imperfect: Mental illness can often impair sexuality, and the studies on SSRI-related sexual dysfunction have been small. "The [pharmaceutical] industry, understandably, has no interest in funding this," Balon noted. (...)

For example, Dr. Cigdem Tanrikut a Massachusetts General Hospital urologist, reported last month at the annual meeting of the American Society for Reproductive Medicine that when 35 normal, healthy men were put on Paxil for five weeks, up to 35 percent of them reported new problems with erections and up to 47 percent reported difficulty ejaculating while on the medication. (...)

But in a small number of patients, it appears, the symptoms continue after stopping the drugs. Based on recent case reports of persistent effects, an article earlier this year in the Journal of Sexual Medicine said patients should "be told that in an unknown number of cases, the side effects may not resolve with cessation of the medication." (...)

Erektil dysfunksjon kan innlede Parkinsons

Erectile dysfunction may precede Parkinson's (Erektil dysfunksjon kan innlede Parkinsons)
reuters.com 26.12.2007
NEW YORK (Reuters Health) - Results of a study suggest an association between erectile dysfunction and an increased risk of developing Parkinson's disease.

The autonomic nervous system, which regulates involuntary bodily functions like heart rate and digestion, is often affected in Parkinson's disease, and erectile function, which is controlled by the autonomic system, is commonly compromised, the study team notes in a report.

"An important question," according to Dr. Xiang Gao, of Harvard School of Public Health, Boston, Massachusetts, and colleagues, "is whether erectile dysfunction precedes the onset of motor symptoms of Parkinson's disease." (...)

SOURCE: American Journal of Epidemiology, December 2007. (...)

Slapp penis gir Parkinsons
side2.no 26.12.2007
Manglende evne til ereksjon kan gi økt risiko for Parkinsons sykdom, hevder studie. (...)

- They describe these effects as a "nightmare" and like "torture"

Antidepressants Now No. 1 Drug Prescribed For Women 18-44
nbc4.com 16.11.2007
High Number Of Prescriptions Worrying Some Experts (...)

But not everyone is so lucky. In fact, about two-thirds of people on these drugs experience side effects, which can be severe and devastating.

Internet bloggers are even sharing their experiences with antidepressants online. They describe these effects as a "nightmare" and like "torture." Common reactions include "weight gain, decreased sex drive and severe stomach cramping."

"Something is going on with these drugs," Zuckerman said. "Not everybody metabolizes them the same way. It doesn't have the same effect on every person and some people are harmed by them."

Casalihno is now exercising to combat her depression. She says a pill wasn't the answer for her.

"I was overloaded with everything and I wasn't really addressing the root of the problems," Casalihno said. (...)

Hvordan leger gjør millioner av oss avhengige

How doctors are turning millions of us INTO addicts (Hvordan leger gjør millioner av oss avhengige)
dailymail.co.uk 19.8.2008
Gina Loxam was feeling a bit low, so she went to see her GP and was prescribed the anti-depressant, Seroxat.

Ten years later, she is still on the drug because the severe mood swings, headaches, fatigue and weight gain she suffers when she tries to come off are unbearable.

Gina, a 52-year-old finance and quality manager, is one of more than 600 people now suing the pharmaceutical company GlaxoSmithKline for damages on the grounds that they were not warned of the possible side-effects, such as personality changes, as well as addiction. (...)

Woman sues over drugs ‘hell’

City women suing over 'addiction' to pills
scotsman.com 31.1.2008
TWO Edinburgh women who claim they became addicted to an antidepressant are heading for a High Court battle with a pharmaceutical giant. (...)

Woman takes on drugs giant
ilkestonadvertiser.co.uk 23.1.2008
AN ILKESTON woman is headed for a High Court showdown with pharmaceutical giant Glaxosmithkline UK in a bid for compensation.
Susannah Anthony says in a writ issued at London's High Court and just made publicly available she has suffered undisclosed personal injuries after taking the drug Seroxat, also known as paroxetine.

Now Miss Anthony is claiming damages of up to £50,000 from the manufacturers in a David and Goliath legal battle. (...)

However, Glaxowsmithkline said : "We believe there is no merit in this litigation. Seroxat has benefited millions of people worldwide who have suffered from depression." (...)

(Anm: Antidepressiva (nytteverdi) (mintankesmie.no).

Woman issues write against drugs company
iccheshireonline.icnetwork.co.uk 22.1.2008
A WESTON woman is headed for a High Court showdown with pharmaceutical giant GlaxoSmithKline UK in a bid for compensation.

Irene Barnes says in a writ issued at London's High Court and just made publicly available that she has suffered undisclosed personal injuries after taking the drug Seroxat, also known as paroxetine. (...)

Punk rocker sues over anti-depressant
theargus.co.uk 22.1.2008
A famed punk rocker claims his life has been ruined by addiction to an anti-depressant drug

Kirk Brandon, perhaps best known for his time with 1980s legends Spear of Destiny, is the latest in a string of people to claim damages against pharmaceutical giants. (...)

Woman sues over drugs ‘hell’
icnewcastle.icnetwork.co.uk 18.11.2007
A NORTH woman who claims her life has been made “hell” after using a controversial drug used to treat depression is suing the manufacturers for £50,000, in what could be a landmark case for the UK if it is successful.

Joanne Luongvan, of Bedlington, Northumberland, has launched a legal battle against pharmaceutical giant Glaxosmithkline (GSK) after using anti-depressant Seroxat . . . which has been linked to at least 50 suicides. Ms Luongvan, who is taking her case to the High Court in London, said she has suffered months of torment as a result of suing the company.

Seroxat was banned for under-18s in 2003 after a Government watchdog found it trebled the risk of suicidal thoughts.

And in January this year, the BBC’s Panorama claimed GSK — the UK’s biggest drugs company — had covered up evidence about the drug’s safety. The programme alleged GSK attempted to show the drug worked for depressed children despite failed clinical trials. The company rejected the claims, but has been bombarded by lawsuits in the US.

Ms Luongvan’s representatives, Cardiff-based legal firm, Hugh James Solicitors, said her case is part of a “group legal action”.

A GSK spokesman said: “We believe there is no merit in this litigation. Seroxat has benefited millions of people worldwide.” (...)

Mor saksøker legemiddelfirma

Mother Sues Drug Company (Mor saksøker legemiddelfirma)
cknw.com 1.3.2008
VANCOUVER/CKNW(AM980) - A Surrey woman and her infant daughter are launching a class-action lawsuit against the manufacturer of a commonly-used anti-depressant medication.

Faith Gibson alleges drug company Glaxo-Smith-Kline didn't adequately warn of the potential side effects for pregnant women taking the drug Paxil. (...)

Seroxat (Paxil i USA) - skader - søksmål -rettssaker

Paxil Side Effects Lawsuit (Søksmål relatert til sideeffekter fra Seroxat)
paxillawsuitsinfo.com 16.9.2011
Many Paxil side effects lawsuit cases have been filed due to extreme severity of health problems or even death experienced by people who took the SSRI antidepressant as prescribed.

Large settlements have been awarded to people through these Paxil side effects lawsuits, as well as settlements awarded to states, through Paxil class action lawsuits.

The FDA has mandated several label changes for this drug because of the outcome of research studies showing increased side effects for some people while using Paxil.

Severe Problems Lead to Paxil Side Effects Lawsuit
There are many Paxil side effects listed on the labeling of this drug. Many of the side effects are not too serious or harmful, like feeling more nervous; feeling drowsy or dizzy, upset stomach or nausea and insomnia.

Paxil Side Effects Lawsuit
A bit more concerning Paxil side effects are muscle problems and rigid muscles, fevers, too much sweating, and memory loss.

However, some people experience extremely dangerous side effects which have been researched by experts and are life altering. These severe Paxil side effects include suicidal ideas as well as tendencies (especially amoung young people), self destructive behavior and violent behavior, and among the worst — birth defects, especially of the hearts of babies. (...)

SSRIs: When anti-depressants go wrong (SSRI-er: Når antidepressiva feiler)
independent.co.uk/ 10.8.2009
Rebekah Beddoe was a young mum who went to her GP for help. A routine prescription for anti-depressants later and her life was spiralling out of control (...)

But it was not until I managed to wean myself off the medication that I realised that the drugs were not a cure for the hell I was going through – they were the cause of it. (...)

The dangers surrounding anti-depressants – particularly SSRIs, which help prolong the effects of neurotransmitters that can lighten mood – are well-publicised. I now know that, in many people, such drugs can create problems, rather than alleviate them. Hundreds of High Court writs have been served against GlaxoSmithKline (GSK), the manufacturer of the anti-depressant Seroxat, since the medication was first prescribed in Britain in 1990. Since then it has been linked to some 50 suicides of adults and children. In 2002, BBC's Panorama programme "The Secrets of Seroxat" alleged that GSK covered up fears about Seroxat's safety, something the firm vehemently denies. It was this documentary that proved to be the turning point for me, even though I live many thousands of miles away. (...)

SEBASTIAN COUNTY: Sides dispute delirium led to husband’s killing of wife
nwanews.com 30.10.2008
GREENWOOD — A Fayetteville psychiatrist said Wednesday that 85-year-old Autry Basham suffered from delirium brought on by pneumonia and a sleep disorder when he slashed the throat of his 83-year-old wife last year. (...)

Ross pointed out that Autry Basham had pneumonia, took the drug Paxil for anxiety and suffered from obstructive sleep apnea. All those factors, which were present on the day of Marie Basham’s death, inhibited his ability to get oxygen to his brain. A lack of oxygen can trigger delirium, she said, especially in the elderly. (...)

Killer claims antidepressant may have caused him to kill (Drapsmann hevder antidepressiva mulig fikk ham til å begå drapet)
by F.T. Norton - Nevada Appeal Staff Writer
nevadaappeal.com 24.10.2008
Convicted murderer Anthony Echols listens to proceedings Thursday in district court on his appeal for a new trial. Echols, who was convicted in 2003 of killing Rick Albrecht, now says withdrawal from Paxil may have caused him kill.

ENLARGE Defense attorney Tod Young testifies Thursday in the First Judicial Court on Anthony Echols’ appeal for a new trial. Young represented Echols in 2003 when he was tried and convicted for the murder of Richard Albrecht.

Paxil withdrawal may have caused a Carson City man in 2000 to shoot his estranged wife's suspected lover to death, and the defense attorney's failure to explore that as a theory should be enough to garner a new trial, an attorney for Anthony Echols argued before the First Judicial District Court on Thursday.

Defense Attorney Richard Cornell offered three witnesses to support the theory that Echols, now 46, was suffering from mental symptoms related to quitting the brand-name antidepressant "cold turkey" when he went to the home of Rick Albrecht on Aug. 5, 2000, and shot the Carson City contractor twice in the head.

The Federal Drug Administration in 2005 issued a recommendation that all patients "should be observed closely for clinical worsening, suicidality, and unusual changes in behavior," when starting, changing or stopping a dosage of the drug. (...)

Glaxo settles U.S. Paxil lawsuit for $40 mln (Glaxo forliker amerikansk Seroxat-søksmål på 40 millioner dollar)
reuters.com 2.10.2008
LONDON, Oct 2 (Reuters) - GlaxoSmithKline (GSK.L: Quote, Profile, Research, Stock Buzz) has agreed to settle a long-standing U.S. case over its antidepressant Paxil by paying insurers $40 million to reimburse health plans that paid for children and adolescents to receive the drug.

Baum, Hedlund, Aristei & Goldman, a law firm representing the plaintiffs, said on Thursday the settlement was approved in the U.S. District Court in Minneapolis.

The agreement ends class-action litigation against Glaxo over the issue, after the British-based drugmaker was sued for allegedly suppressing studies showing the drug was not suitable for children.

Last year, Glaxo agreed to pay $64 million to consumers in another class-action settlement. In both cases Glaxo did not admit liability. (...)

DrugSettlement.com Reports That The First Federal Paxil Birth Defect Case Has Been Set For Trial
1888pressrelease.com 1.10.2008
DrugSettlement.com reports that in the case of Hayes v. SmithKline Beecham Corporation, Justice Claire V. Eagan of The United States District Court for the Northern District of Oklahoma, has ordered that the case begin trial on January 20, 2009.

New York, NY (1888PressRelease) October 01, 2008 - DrugSettlement.com, LLC, http://drugsettlement.com, reports that one of its member firms, Nix & McIntyre, LLP, http://oklahomainjurylaw.com, has been ordered by Judge Claire V. Eagan of the United States District Court for the Norther District of Oklahoma, to commence the first federal Paxil Birth Defect trial on January 20, 2009. (...)

US District Court in Pennsylvania Rules Wrongful Death Claim Against Paxil Maker Can Proceed
redorbit.com 23.9.2008
The Food, Drug and Cosmetic Act does not preempt a state-law wrongful death claim that a teenager's suicide was caused by the antidepressant Paxil, a U.S. District Court in Pennsylvania has ruled. During 2001 and 2002, a 15-year-old suffering from body dysmorphic disorder was prescribed Paxil. In September 2002, he committed suicide. (...)

Ingar Holst i kinesisk helse-eksil
vg.no 8.9.2008
(...) Holst mener norsk helsevesen for ofte gjør en dårlig vurdering av pasienter som oppsøker lege med tidlige symptomer på ME, men innrømmer at det er en svært vanskelig sykdom både å diagnostisere og å behandle.

Han mener det er en sammenheng mellom utskriving av SSRI-preparater (Selective Serotonine Reuptake Inhibitors) og utbredelsen av ME. Han sier at Tidsskrift for den norske Lægeforening nekter å ta inn en artikkel der han beskriver det han mener er sammenhengen mellom reseptmedisiner og den enorme utbredelsen av ME i Norge. Les artikkelen på http://me.holst.no.

Holst mener dette kan føre til permanente problemer i serotoninstoffskiftet og dermed en forverring av ME-utviklingen. (...)

Baum, Hedlund, Aristei & Goldman Achieves 3rd Preemption Win This Year on Behalf of Their Clients in Paxil Suicide Case
expertclick.com 3.9.2008
A federal judge in Pennsylvania ruled on Friday, August 29, 2008, that a lawsuit filed by the parents of a 16-year-old New Jersey boy who committed suicide while taking Paxil is not preempted by federal law, as Paxil’s manufacturer, GlaxoSmithKline (GSK), had hoped. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Parkersburg family files Paxil lawsuit
wvrecord.com 14.8.2008
PARKERSBURG -- A Wood County family has filed a federal lawsuit against GlaxoSmithKline over its drug Paxil after their son was born with birth defects.

Gerald and Paula McGee of Parkersburg filed the lawsuit in U.S. District Court on Aug. 11. (...)

UNDERSTANDING PAXIL LAWSUIT GETS BETTER (Forståelsen av Seroxat-søksmål blir bedre)
BESTSYNDICATION.COM 8.8.2008
There are many antidepressant drugs available. These drugs are used to affect the chemicals that carry information and signals to the brain called neurotransmitters. Among one of the most common drugs used to treat depression is Paxil. (...)

There have been increasing amounts of Paxil users that are complaining about the serious side effects that go hand in hand with this drug. Paxil is reported to be highly addictive, cause even more manic behavior, and can even increase feelings of suicide. Withdrawal from Paxil can cause anxiety, panic attacks and a relapse of worsening depression. There have even been reports done to show that Paxil causes abnormal bleeding and brain tumors.

If you have been prescribed Paxil and are now experiencing the deadly side effects of the drug you are eligible to file a Paxil Lawsuit. (...)

Paul Justice gives advice to clients who are looking for attorneys to handle injury related cases such as Paxil birth defect,Paxil side effect. To know more about Paxil attorneys, Paxil Lawsuit and paxil birth defect lawyers visit www.paxilattorneys.com (...)

Lancs women sue over 'sunshine' pill
lep.co.uk 2.6.2008
Two Lancashire women face a High Court showdown with a pharmaceutical giant over claims their lives were blighted by a so-called wonder drug.
Designed to restore confidence, GlaxoSmithKline UK's Seroxat was billed as the "sunshine pill" as it helped patients with their depression.

But several hundred people want to sue the drug manufacturer claiming the anti-depressant ruined their lives with horrendous side-effects, while others say they have become addicted to it.

Michelle Dewhurst, 38, of Grimsargh, Preston, is one of the many claimants seeking up to £50,000 for personal injuries and other losses suffered as a result of using Seroxat.

The mum-of-one claims the drug's "terrible side-effects" robbed her of years of her life and says she found it difficult to come off the anti-depressants. (...)

Four years ago David Carmichael killed his son. Now free, he is crusading against 'happy drugs,' saying they -- not him -- are to blame
torontosun.com 25.5.2008
He popped his antidepressants like candy and believes Paxil made him kill his son.

And now David Carmichael is worried drug companies will soon have the go-ahead to push their potentially dangerous "happy pills" on more unsuspecting Canadians, with similarly dire results.

With new Bill C-51, the Conservative initiative to overhaul Canada's food and drug act, critics like Carmichael worry it will open the door to big pharma circumventing the current ban on direct-to-consumer advertising. (...)

Withdrawal Symptoms From Paroxetine May Last For A Long Time (Seponeringssymptomer fra Seroxat (paroxetine) kan vare i lang tid)
medicalnewstoday.com 17.1.2008
(...) Now researchers at the University of Bologna headed by Prof. G.A. Fava confirm their account in an article published in the December 2007 issue of the International Journal of Neuropsychopharmacology. (...)

Now researchers at the University of Bologna headed by Prof. G.A. Fava confirm their account in an article published in the December 2007 issue of the International Journal of Neuropsychopharmacology. (...)

Patients were assessed with the Discontinuation-Emergent Signs and Symptoms (DESS) checklist 2 wk, 1 month and 1 yr after discontinuation. Nine of the 20 patients (45%) experienced a discontinuation syndrome, which subsided within a month in all but three patients who had been taking paroxetine for a long time. Discontinuation syndromes appeared to be fairly common even when performed with slow tapering and during clinical remission. In some cases disturbances persisted for months after discontinuation. (...)

CITY BUSINESS ACE TO SUE DRUG GIANT OVER MEDICINE thisisnorthscotland.co.uk 29.1.2008
An award-winning young entrepreneur from the north-east is ready to do battle in court with one of the biggest drug companies in the world.

Stuart Ebdy wants to sue GlaxoSmithKline (GSK) for £50,000 because he claims one of its products caused him "personal injuries". (...)

The 25-year-old and hundreds of other Seroxat users worldwide claim their lives have been blighted by addiction to the drug - GSK's biggest-selling antidepressant.

Some users say they have contemplated suicide after taking it, although it is designed to restore their happiness and confidence. (...)

During her trial, Kerry Magee said: "I had been suffering from depression for some time. I was put on Seroxat, which I did not feel helped any."

A TV documentary team investigated the drug and its side effects in 2003 and claimed it had a "dark side" that led to users suffering "serious" withdrawal symptoms when they tried to stop using it. (...)

However, Mark Harvey, a solicitor acting for people in a similar situation, said: "All the claimants allege that they tried to withdraw from Seroxat and have suffered discontinuation syndrome." (...)

£50,000 bid in drug case
thestar.co.uk 26.1.2008
A SECOND Sheffield resident is launching legal action against medical giants GlaxoSmithKline UK in a bid to net up to £50,000 in compensation.
The man, from Firth Park, claims he suffered undisclosed personal injuries after taking the widely prescribed anti-depressant drug Seroxat which is manufactured by the global company. (...)

Solicitor Mark Harvey, who is acting for many of the claimants, said: "All the claimants allege that they tried to withdraw from Seroxat and have suffered discontinuation syndrome." (...)

(Anm: Personal Injury Experts Investigate Claims Against Addictive Antidepressant - Hugh James and Secretary of the Association of Personal Injury Lawyers (APIL). antidepressantsfacts.com (26.1.2008).)

MAKER OF 'HAPPY PILL' SEROXAT IS SUED BY MAN WHO KILLED WIFE WHILE ON DRUG
THISISLONDON.CO.UK 20.1.2008
Murderer Colin Dorey, who battered his wife to death with a hammer, is suing pharmaceuticals giant GlaxoSmithKline over his use of the anti-depressant Seroxat.

From his cell at Gartree prison in Leicestershire, Dorey, 48, has joined nearly 500 other users of the drug in a lawsuit against the multi-national, each seeking compensation of up to £50,000.

Their case is funded by legal aid at an estimated cost of hundreds of thousands of pounds to the taxpayer. (...)

CITY FATHER CLAIMS DRUG MADE HIM SUICIDAL
thisisexeter.co.uk 20.11.2007
A CLAIM for thousands of pounds in compensation has been made by a father-of-two who says he felt suicidal after becoming addicted to a controversial anti-depressant.

Colin Channing claims Seroxat also made him angry, extremely emotional and severely depressed.

The 49-year-old has filed claims against the drug's manufacturer, GlaxoSmithKline, at the High Court. He is hoping to get up to £50,000 damages for loss of earnings and prescription costs.

Seroxat was banned for under-18s in 2003 after a Government watchdog found it trebled the risk of suicidal thoughts in depressed children. (...)

Sufferers sue happy pill firm for 30million (Skadelidte saksøker lykkepillefirma for 30 millioner pund)
dailymail.co.uk 17.11.2007
'Happy pill': Users say GSK's drug Seroxat is addictive and they want compensation

Pharmaceutical giant Glaxo-SmithKline is facing a £30million damages claim from users of its anti-depressant Seroxat.

Lawyers representing patients who insist the bestselling drug is addictive have issued the first of 600 High Court writs against the company, each seeking compensation of up to £50,000.

Since first prescribed in Britain in 1990, Seroxat has been linked to at least 50 suicides of adults and children. (...)

GlaxoSmithKline said: "Seroxat has benefited millions of people worldwide.
"We believe the product is not defective and that there is therefore no merit in this litigation." (...)

Talking with a Paxil Attorney Could Save your Life!
attorney.lawreferenceonline.com 9.11.2007
Have you recently been harmed or injured in some way because of the Paxil medication that you have been taking? Do you suffer from heart problems, breathing problems or a number of other problems that was initiated by using the Paxil medication? Do you have increased thought of suicide even while you are taking Paxil? If you answered yes, then talking with a Paxil attorney could possible save your life or the life of your loved ones. Today, there are several Paxil lawyers available to help you with your Paxil related claim. (...)

It is important to know that the drug Paxil is manufactured by a company known as GlaxoSmithKline Company. Many lawyers believe that the GlaxoSmithKline Company may have hidden some very important, yet dangerous facts about the Paxil medication. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

GlaxoSmithKlines er saksøkt over antidepressivaet Seroxat

City women suing over addiction to pills
scotsman.com 2.2.2008
TWO Edinburgh women who claim they became addicted to an antidepressant are heading for a High Court battle with a pharmaceutical giant.

Barbara Hood, from Newhaven, and Josephine Isles, from Meadowbank, are claiming damages of up to £50,000 from GlaxoSmith-Kline UK. They claim they became ill after stopping taking the drug Seroxat, one of the world's best selling antidepressants. (...)

Happy pills’ case to go to high court (Lykkepillesak til høyesterett)
dailypost.co.uk 28.1.2008
(...) The government has announced an inquiry into Selective Serotonin Reuptake Inhibited drugs, known as SSRI, such as Seroxat and Prozac.

GlaxoSmithKline said: “We believe there is no merit in this litigation. Seroxat has benefited millions of people worldwide who have suffered from depression.”

The writ was issued by South Wales law firm Hugh James in November. (...)

GSK says UK lawsuit on Seroxat is without merit (GSK sier det britiske Seroxat-søksmålet er grunnløst)
pharmatimes.com 10.1.2008
GlaxoSmithKline has again spoken out in defence of Seroxat as reports re-emerged concerning lawsuits being filed in the UK against the firm and its blockbuster antidepressant. (...)

GlaxoSmithKline Is Sued in U.K. Over Antidepressant Seroxat (GlaxoSmithKlines er saksøkt i Storbritannia over antidepressivaet Seroxat)
bloomberg.com 8.1.2008
Jan. 8 (Bloomberg) -- GlaxoSmithKline Plc is being sued for as much as 15.7 million pounds ($31 million) by several hundred U.K. patients who said it was difficult to stop taking the antidepressant Seroxat.

``The claims are being brought here by people who allege they've had withdrawal,'' Mark Harvey, the lawyer who filed the suit in London, said today.

The U.K. lawsuit seeks between 15,000 pounds and 50,000 pounds each on behalf of 314 people who allege personal injury from Seroxat, known in the U.S. as Paxil, according to the Dec. 19 filing and the London High Court register. The patients claim negligence or statutory breach of duty dating back to 1997.

GlaxoSmithKline is also the target of more than 4,000 lawsuits in the U.S., combined in a federal court in Los Angeles, that allege Paxil users suffered withdrawal symptoms. While Harvey said he was aware of the U.S. lawsuits, the U.K. action is separate.

"We believe there is no merit in this litigation,'' GlaxoSmithKline said in an e-mailed statement today. "Seroxat has benefited millions of people worldwide who have suffered from depression.'' (...)

Seroxat (Paxil) og andre SSRI-er kan utløse personlighetsendringer, aggresjon og drap

Courtney Love apologises for her wild and inappropriate behaviour (including recent naked interview)
dailymail.co.uk 11.11.2010
Courtney Love has apologised for behaving in a wild and inappropriate manner during a recent interview with a newspaper reporter.

The singer's interview with New York Times reporter Eric Wilson lived 'right up to my worst reputation,' as she put it.

Love, 46, claims she was drunk and on antidepressant Zoloft when she met Wilson in her hotel room for the interview, which explains why she wasn't wearing any clothes at the time. (...)

KTLA SPECIAL REPORT: Fmr. Cop Accused Of Rape Blames Anti-Depressant Medication
ktla.com 10.11.2010
Anthony Orban's wife stands by her husband and says, "Something happened to his brain. There's no denying what happened."

ONTARIO ( KTLA) -- Former Westminster police officer Anthony Orban is accused of kidnapping and raping a woman but his defense attorney says he was taking zoloft and neurontin -- anti-depressant medication -- that rendered him incapable of rational thought.

Orban -- an Iraq War vet and former cop -- has been in jail since April of this year. On April 3rd, Orban and a friend -- Jeff Jelinek -- spent the afternoon in Ontario, drinking margaritas and beer.

Orban was on prescription anti-depressants and in an exclusive interview with KTLA, his wife Tracy says, "Something happened to his brain. There's no denying what happened." (...)

Orban's sister, Tisha, his mother Margaret, and his wife are convinced that Orban snapped because of the anti-depressant prescription drugs he was taking.

His attorney, Jim Blatt says, "He has absolutely no recollection of the events. The reason here... The use of psychotropic drugs. Zoloft and Neurontin, causing a psychotic break from reality." (...)

Grapevine woman: Emotional distress caused her to kill grandmother
star-telegram.com 26.5.2008
(...) About that time, Courtney Dunkin said, she was prescribed Paxil, an antidepressant on which she would intentionally overdose on a few occasions. In 2004, the Food and Drug Administration began requiring its strongest label warning for Paxil and other antidepressants because they increase the risk of suicidal thinking and behavior in children.

Dunkin says she was suicidal at the time of her grandmother's death and irrational because of the medication and the death of her grandfather. (...)

Accused murderer's sister blames crime on antidepressants
ksl.com 5.3.2008
Family members of murder suspect David Ragsdale today proclaimed they believe he is innocent of the murder of his estranged wife, Kristy. They believe he was under the influence of antidepressants, which clouded his judgment and led him to kill his wife. (...)

Tamara Ragsdale, David's sister, said, "She was writing him different prescriptions. He was on Paxil, Doxopine, Ritalin, Provigil; two of those are speeds, two are anti depressants, and he was on two forms of testosterone. He was having severe, adverse reactions before the shooting, blacking out and that sort of activity." (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Psychiatrists testify in nail gun murder trial
theunion.com 15.11.2007
Defense says Williams didn't know what he was doing (...)

In 2002, he testified in a civil case against pharmaceutical company GlaxoSmithKline, which was claiming in advertisements that Paxil is non-habit forming. Shipko testified the company was misleading consumers into thinking they could stop taking the drug at any time, but that withdrawal symptoms can be severe.

According to the U.S. Food and Drug Administration, possible side-effects of Paxil therapy include changes of mood and suicidal thoughts or actions when the drug is first taken or when the dose is changed. There is no mention in the FDA's patient information sheet on Paxil regarding homicidal thoughts or actions.

Deputy District Attorney Kathryn Francis, with former Assistant District Attorney Ron Wolfson assisting her in court, called on psychiatrist Dr. Eric Raimo of San Diego to refute Shipko's testimony. (...)

'He shot her, reloaded, then shot her again'
theunion.com 3.11.2007
(...) Williams found out about the affair while he eavesdropped on a call between his wife and her friend a month before the killing. The stress of the betrayal combined with side effects from withdrawal of his anti-depressant medication Paxil drove him to kill, he said.

"Rather than a cold, calculated, angry plan, his decision to stop taking Paxil led to an incredible state of unconsciousness," Munkelt said. "He was trapped inside his own living nightmare." (...)

Baum Hedlund tar ut søksmål mot Seroxat-produsent på vegne av barn født med alvorlige hjertedefekter

Baum Hedlund Files Lawsuit Against Paxil-Maker on Behalf of Child Born with Severe Heart Defects
pharmalive.com 28.7.2006
LEGAL ACTIONS
PHILADELPHIA--(BUSINESS WIRE)--Jul 28, 2006 - Baum Hedlund filed a lawsuit today against Philadelphia-based GlaxoSmithKline ("GSK"), the maker of Paxil, in Pennsylvania State Court, on behalf of its clients Anthony and Matilda Vasquez of Bedford, Texas, and their son Adrian. The family alleges that Mrs. Vasquez's ingestion of Paxil during her pregnancy resulted in her son being born with severe heart defects. The Vasquez family is seeking an unspecified amount of damages against GSK for failing to warn about the risks associated with Paxil for pregnant women and their unborn children. (...)

Gardener's terror rampage with chainsaw and petrol

Gardener's terror rampage with chainsaw and petrol
scotsman.com 26.8.2006
A GARDENER brought terror to neighbours and police when he went on a rampage with a chainsaw, a court heard yesterday.

James Aitken, 33, sawed his way through doors and furniture as a family barricaded themselves in a bedroom. He also sawed the wing mirror from a van before torching it.

When police were called to the scene in Whitecraig, East Lothian, Aitken doused officers with petrol and threatened them by flicking his lighter before he was finally brought down by baton blows and CS gas.

At the High Court in Edinburgh, judge Lord Brodie described the events of the early house of 26 February as "bizarre". Solicitor advocate John Scott, defending, said attempts had been made to link Aitken's behaviour to a controversial anti-depressant, seroxat. (...)

Glaxo May Have Shipped Inactive Paxil Antidepressants

Glaxo May Have Shipped Inactive Paxil Antidepressants (Update2)
bloomberg.com 4.10.2006
Oct. 4 (Bloomberg) -- GlaxoSmithKline Plc, the world's second biggest drugmaker, recalled Paxil CR antidepressants last month because the pills may have lacked an active ingredient, and didn't warn patients. (...)

Doctors said the lack of a warning could mean that patients may face a sudden withdrawal that can spur suicidal thoughts, shooting pain and flu-like symptoms. The Paxil CR pills Glaxo recalled, the highest dose sold, can cause severe withdrawal symptoms, said Stephen Ellen of the University of Massachusetts Medical School in Worcester.

"If it is true that patients might have gotten dummy pills without knowing it, it is outrageous,'' said Ellen, a psychiatrist who is medical director of the Counseling Center of Nashua, New Hampshire, the largest private psychiatric group practice in New England with about 6,000 patients annually. (...)

SSRI-preparater og mulige MS-liknende hjerneskader

Antidepressant linked to worsening white matter in elderly (Antidepressiva linket til forverring av hvit substans hos eldre)
rehabpub.com/reuters_article.asp 17.3.2008
NEW YORK (Reuters Health) - The results of a study employing serial cranial MRI suggest that elderly adults who use tricyclic antidepressants may be at increased risk for progression of white matter lesions, which have been linked with late-life depression by previous studies. (...)

The use of an antidepressant from any class during the study period hastened the progression of white matter disease, according to the report in the March issue of Stroke.

Contrary to what the investigators had hypothesized, SSRI use did not reduce, but slightly increased the risk of worsening white matter on multivariate analysis. Still, the 36% increased risk seen with these agents was not statistically significant.

The use of a tricyclic antidepressant, however, was associated with a significantly elevated risk of worsening white matter lesions. Compared with those who used no antidepressants, patients receiving an agent in this drug class had an increased risk of 77%. (...)

(Anm: Antidepressant Treatment and Worsening White Matter on Serial Cranial Magnetic Resonance Imaging in the Elderly. Stroke 2008;39:857-862.)

(Anm: hvit substans; hvit substans, margkledde nervefibrer, utløpere fra nervecellene i hjerne og ryggmarg. Den hvite fargen skyldes myelin, et fettholdig stoff som danner margskjeder omkring nervefibrene. Kilde: Store norske leksikon.)

(Anm: white matter (hvit substans); Multiple Sclerosis (MS) is one of the most common disease which affects white matter (wikipedia.org).)

(Anm: Magnetic resonance imaging MRI findings in white matter disease of brain. J Pak Med Assoc. 2008 Feb;58(2):86-8.)

Selective serotonin reuptake inhibitor use associates with apathy among depressed elderly: a case-control study (Bruk av selektive serotoninreopptakshemmere er assosiert med apati blant deprimerte eldre: en case-control studie)
Annals of General Psychiatry 2007, 6:7
Background (Bakgrunn)
Det er det siste ti år rapportert at bruk av selektive serotoninreopptakshemmere (SSRI-er) kan være assosiert med forekomst av apati. (...) (It has been reported for over the past decade that the use of selective serotonin reuptake inhibitors (SSRI's) may associate with the emergence of apathy.)

Conclusion (Konklusjon)
Selv om depresjon ble bedre hos eldre pasienter som fikk antidepressiva, opptrådte apati oftere hos pasienter som ble behandlet med SSRI enn hos pasienter som ikke ble behandlet. Dysfunksjon i frontal lobe på grunn av serotonerge endringer er ansett som en av mulighetene. (...) (Even though depression was improved in elderly patients receiving antidepressants, apathy appeared to be greater in patients who were treated with SSRI than that found in patients who were not. Frontal lobe dysfunction due to alteration of serotonin is considered to be one of the possibilities.)

(Anm: apati (av gr. nektende a og 'affekt'), psykologisk og psykiatrisk begrep som betyr mangel på sjelelige følelser (affekter). Som regel ledsaget av interesseløshet. Sees særlig ved svære depressive og schizofrene tilstander.

(Anm: pannelappen; lobus frontalis, hjernens frontallapp; jf frontallappssyndromet EN frontal lobe.

frontallappssyndromet; eit særleg huglag (sinnelag) som kan koma etter skade i ein pannelapp i hjernen, t d etter lobotomi; pasienten får eit grunt kjensleliv, vert urimeleg overflatisk og lett til sinns, likesæl og godtruande; også kalla frontal psyke; jf Witzelsucht (ty.) EN frontal lobe syndrome. Kilde: Norsk medisinsk ordbok.)

Vanlige utfall etter ervervet hjerneskade
sunnaas.no 26.2.003
(...) Det er rapportert at noen pasienter blir passive og apatiske. Noen er det fordi de har blitt deprimerte, mens det for andre er et direkte resultat av skaden. Noen blir også urolige og kritikkløse. Ofte er slike endringer i oppførsel det de pårørende synes er vanskeligst å forholde seg til. (...)

THE PEOPLE'S PHARMACY
infoweb.newsbank.com 14.7.2007 (The Dallas Morning News)
Serotonin has become a household word, thanks to Prozac. Millions of people take this popular antidepressant or related drugs such as Zoloft and Paxil every day.

These medications are known scientificallyas SSRIs: selective serotonin reuptake inhibitors. They allow serotonin to accumulate between nerve endings. This brain chemical helps to regulate mood and appears to be important for sleep, learning, appetite, sexual behavior, pain, perception and movement.

But although serotonin is essential for good health, it has a darker side. Too much serotonin can cause bizarre behavior, and some people taking these medications might be at risk of life-threatening drug interactions.

Serotonin syndrome can cause a range of problems, from anxiety, agitation and muscle twitches to nausea, sweating, confusion, convulsions and even coma. (...)

"...forstyrret følesans og opplevelser av "elektriske støt" i hodet" (...) "...følelse av elektriske støt i hodet, andre blir svimmel og psykisk urolig"

Hva er antidepressivt nedtrappingssyndrom?
pasienthandboka.no/ 17.4.2007
Stans i behandlingen med antidepressiv medikasjon (antidepressiva) er noen ganger forbundet med utvikling av et såkalt "antidepressivt nedtrappingssyndrom" (syndrom betyr samling av mange symptomer). Symptomene kan være forkjølelsesliknende, søvnproblemer, kvalme, svimmelhet, forstyrret følesans og opplevelser av "elektriske støt" i hodet. Alle typer antidepressiva er rapportert å kunne gi slike reaksjoner, enten som følge av brå stans eller for rask nedtrapping av behandlingen. De mest brukte antidepressiver betegnes SSRI (Fluoxetin, Fontex, Citalopram, Cipramil, Paroxetin, Seroxat, Sertralin, Zoloft, Fevarin, Cipralex), trisykliske antidepressiver (Klomipramin, Anafranil, Surmontil, Sarotex, Noritren, Sinequan) og MAO-hemmere (Moklobemid, Aurorix). Atypiske antidepressiver er Mianserin, Tolvon, Mirtazapin, Efexor, Edronax, Cymbalta, Yentreve.
Kjennskap til antidepressivt nedtrappingssyndrom er viktig fordi selv om symptomene ofte er milde, kan tilstanden gi mye ubehag, fravær fra jobb, andre psykososiale problemer og unntaksvis kreve sykehusinnleggelse. (...)

SSRI mot depresjon
pasienthandboka.no 27.2.2008
(SSRI betyr selektiv, serotonin reopptaks inhibitor) (...)

Mange er redd for avhengighet ved bruk av nervemedisiner. Medikamentene som brukes ved depresjoner gir ingen ruseffekt eller umiddelbar lykkefølelse, og heller ikke avhengighet (derfor er tilnavnet lykkepiller misvisende). Derimot kan man oppleve ubehag når man slutter med medisinene. Mange beskriver en følelse av elektriske støt i hodet, andre blir svimmel og psykisk urolig. Dette kan være skremmende dersom man ikke vet om det. Denne bivirkningen kan man unngå eller betydelig redusere ved å trappe langsomt ned dosene når man slutter. (...)

Hvilke symptomer ser vi ved MS?

Hvilke symptomer ser vi ved MS?
MS.NO 4.12.2002
SYMPTOMER
MS omfatter inflammasjon i sentralnervesystemet som etterfølges av tap av de beskyttende myelin skjedene som omgir nervefibrene [demyelinisering]. Myelinet virker som isolasjonsmateriale som omgir og beskytter elektriske ledninger. Når myelinet tar skade vil ikke nerveimpulsene kunne overføres så hurtig og effektivt som de skal. Som et resultat av den inflammatoriske prosessen vil det oppstå skadde områder [lesjoner eller plaques] i hjerne og ryggmarg som i sin tur gir ulike nevrologiske symptomer.

Vanlige symptomer kan være synstap, nummenhet og vissenhet, kraftsvekkelse, ustø gange, dobbeltsyn, økt trøttbarhet, varmeintoleranse, delvise eller fullstendige lammelser og en fornemmelse av elektrisk støt langs ryggsøylen ved bøyning i nakken. Symptomene kan forsvinne etter et akutt attakk, men kan også bli værende. (...)

Antidepressiva ødelegger ansiktsmuskulatur, og gir økt aldring

Divorce, Antidepressants, Or Weight Gain/Loss Can Add Years To Your Face (Skilsmisse, antidepressiva, eller vektøkning/vekttap kan legge år til ditt ansikt)
medpagetoday.com 4.2.2009
Your mother's wrinkles -- or lack there of, may not be the best predictor of how you'll age. In fact, a new study claims just the opposite. The study, involving identical twins, suggests that despite genetic make-up, certain environmental factors can add years to a person's perceived age. Results just published on the web-based version of Plastic and Reconstructive Surgery(R), the official medical journal of the American Society of Plastic Surgeons (ASPS), reveal that factors like divorce or the use of antidepressants are the real culprits that can wreak havoc on one's face. (...)

During the study, Dr. Guyuron and his colleagues obtained comprehensive questionnaires and digital images from 186 pairs of identical twins. The images were reviewed by an independent panel, which then recorded the perceived age difference between the siblings.

Results showed that twins who had been divorced appeared nearly 2 years older than their siblings who were married, single or even widowed. Antidepressant use was associated with a significantly older appearance and researchers also found that weight played a major factor too. In those sets of twins who were less than 40 years old, the heavier twin was perceived as being older, while in those groups over 40 years old, the heavier twin appeared younger. (...)

Additionally, researchers suspect that continued relaxation of the facial muscles due to antidepressant use, could account for sagging. (...) (I tillegg mistenker forskerne at den vedvarende avslapping av ansikstmuskler som antidepressiva forårsaker, kan forklare årsaken til at ansiktet faller sammen (henger).)

(Anm: Plastic and Reconstructive Surgery. Factors Contributing to the Facial Aging of Identical Twins (Note: This study is appearing in a raw, publish-ahead-of-print format and will be published in final form in the April 2009 issue of PRS.) (February 2009).)

Trikset for å unngå rynker
dinside.no 4.2.2009
Forskning viser at du selv kan påvirke.

Det er langt fra bare alder og genetiske faktorer som avgjør om du blir rynkete i ansiktet. Det kommer fram i en fersk studie publisert i tidsskriftet Plastic and Reconstructive Surgery. (...)

Stress er synderen
Testpersoner som hadde brukt antidepressiva eller som hadde gått kraftig opp og ned i vekt også så eldre ut enn tvillingen sin. (...)

Antidepressiva kan dessuten føre til at ansiktshuden henger mer, fordi medisinen gjør at ansiktsmuskulaturen blir mer avslappet. (...)

What happens when minnows take a chill pill? (Hva skjer når småfisk tar en avslapningspille)
startribune.com 22.12.2008
Meghan McGee, a graduate student at St. Cloud State University, tested minnow larvae reaction time to vibrating movement.

St. Cloud State University research found that minnows exposed to antidepressants, whose residues end up in local waters, are more laid back - which is not so great for survival. (...)

FIKK 2,2 MILL. etter ansiktskramper (PDF)
Av JORUN SOFIE F. AARTUN og MAY LINN GJERDING
VG 22.05.2006 (Side: 9. Emne: Helse. Kategori: HELSE OG MEDISIN)
En 51 år gammel kvinne fikk utbetalt hele 2,2 millioner kroner i erstatning, etter at «lykkepiller» ga henne kroniske rykninger i ansiktet. Informasjonssjef Torill Svoldal Stæhr i Norsk Pasientskadeerstatning (NPE) ser svært alvorlig på saken.

- Kvinnen har fått store skader. I tillegg til de kroniske muskeltrekningene i ansikt, hals og mellomgulv har kvinnen store pustebesvær, sier Svoldal Stæhr i NPE.

Hun mener det er overveiende sannsynlig at kvinnen fikk de lumske skadene som følge av såkalte SSRI-preparater, som «lykkepillene» heter på fagspråket.

- Store smerter
- Kvinnen har store smerter og er delvis eller helt ufør etter å ha tatt preparatet Fontex, sier Svoldal Stæhr.

Fontex, bedre kjent som Prozac, skal virke mot depresjon, angst, spiseforstyrrelser, narkolepsi og andre psykiske lidelser.

Det foreligger en potensiell risiko for kramper ved behandling med antidepressive legemidler. (...)

Deprimerade patienter misstros av vården

Deprimerade patienter misstros av vården
tv4.se 12.11.2004
Karin Sörensen fick kramper men misstroddes av läkarna.

Patienter blir inte trodda när dom berättar om sina biverkningar av antidepressiva medel - som att de får självmordstankar, blir apatiska och känner sig beroende av medicinen. (...)

Karin Sörensen är av de drabbade
- Bemötandet var det värsta. Att inte bli trodd av läkarna. De sade att den här medicinen kommer att fungera, men sen när den inte fungerade så sade de aha, men då är det något annat än medicinen, säger hon. (...)

- Sedan spred det sig så jag fick riktiga krampanfall i hela kroppen. Och när jag talar om det för läkare så sade de att det kan inte vara medicinen men jag slutade med den och sen har jag aldrig haft krampen igen. (...)

Dementeras av läkare
Kilen är en intesseorganisation dit konsumenter kan rapportera läkemedelsbiverkningar. Många är desperata när de ringer om biverkningar som dementeras av läkare, trots att biverkningarna ibland finns nämnda i Fass, uppslagsboken för läkemedel.

- Det här är ju oerhört förvirrande för en patient att det står i Fass trots att doktorn säger att det inte är det. Och då förlorar man förtroendet för läkaren, man förlorar förtroendet för läkemedlet och man slutar en behandling som kanske kunnat hjälpa, säger Jan Albinson på Kilen. (...)

Lyckopiller får många att må ännu sämre
tv4.se 11.11.2006
Över en halv miljon svenskar använder antidepressiva läkemedel, så kallade lyckopiller. Men mer än hälften måste byta medicin för att biverkningarna är för svåra. (...)

Kända biverkningar är illamående, sexualstörningar och känslan av vara avskärmad från omgivningen. (...)

Veteraner som tar PTSD-legemidler dør under søvn

Vets taking PTSD drugs die in sleep (Veteraner som tar PTSD-legemidler dør under søvn)
wvgazette.com 25.5.2008
Hurricane man's death the 4th in West Virginia

A Putnam County veteran who was taking medication prescribed for post-traumatic stress disorder died in his sleep earlier this month, in circumstances similar to the deaths of three other area veterans earlier this year.

Derek Johnson, 22, of Hurricane, served in the infantry in the Middle East in 2005, where he was wounded in combat and diagnosed with post-traumatic stress disorder while hospitalized.

Military doctors prescribed Paxil, Klonopin and Seroquel for Johnson, the same combination taken by veterans Andrew White, 23, of Cross Lanes; Eric Layne, 29, of Kanawha City; and Nicholas Endicott of Logan County. All were in apparently good physical health when they died in their sleep.

Johnson was taking Klonopin and Seroquel, as prescribed, at the time of his death, said his grandmother, Georgeann Underwood of Hurricane. Both drugs are frequently used in combination to treat post-traumatic stress disorder. Klonopin causes excessive drowsiness in some patients. (...)

Veterans' families question cause of deaths
wvgazette.com 1.3.2009
Post-traumatic stress syndrome treatment cited

CHARLESTON, W.Va. -- Stan and Shirley White's son Andrew, a Marine reservist, died at home 2 1/2 years after he returned from Iraq. Janette Layne lost her husband, Eric, in similar circumstances after his return from Iraq.

More than a year later, they still don't know if the medication their loved ones were taking for post-traumatic stress disorder contributed to their deaths. (...)

The prescriptions were given by doctors at VA facilities in Huntington, Charleston and a residential program in Cincinnati where Layne had just completed an eight-week in-patient treatment. White's doctor instructed him to take as much Paxil and Seroquel as needed, Shirley White said.

"They said he had lethal amounts in his system," she said. "So, no, we don't have answers."

A second look
Stan White hopes to convince policy-makers in Washington to take a second look at pharmaceuticals prescribed to PTSD sufferers.

How safe are the combinations? How carefully should they be dosed? Should people with PTSD, which sometimes includes forgetfulness and memory loss, be given prescriptions that require careful monitoring? (...)

(Anm: Paxil (Seroxat; generisk navn paroxetine; paroksetin i Norge).

Kramper (convulsions) og hjernehinnebløding (subarachnoid haemorrhage) etter inntak av SSRI (lykkepiller)

Neonatal convulsions and subarachnoid hemorrhage after in utero exposure to paroxetine. (Kramper og subaraknoidalbløding (hjernehinnebløding) hos nyfødte etter bruk av Seroxat under svangerskapet)
Rev Neurol 2003;36:724-6
CASE REPORT. One newborn whose mother had been treated with paroxetine 20 mg/day during pregnancy, presented convulsions and subarachnoid haemorrhage in the first six hours of life. The newborn did not present symptoms of hypoxic ischaemic encephalopathy, withdrawal syndrome, infection, metabolic alterations, cerebral malformations or coagulopaties. DISCUSSION. The most probable etiology is that the paroxetine could decrease the seizure threshold, taking place the first seizure during delivery. The difficult fetal extraction would have provoked the subarachnoid haemorrhage in a patient with an impaired haemostatic function due to a depletion of platelet serotonin and may also contribute the increased vascular fragility due to paroxetine and reported in adults or in animals. CONCLUSION. Neonatal convulsions and subarachnoid haemorrhage may occur after paroxetine treatment in the third trimester of pregnancy. An accurate follow up of these newborns in the firsts days of life is strongly recommended.” (...)

(Anm: subaraknoidalbløding; hemorrhagia subarachnoidalis; hjernehinnebløding, d e bløding mellom araknoidea og pia, oftast frå ei rivna utposing eller utviding (divertikkel, aneurisme) på ei av hjernepulsårene; slike alvorlege blødingar kan koma hos unge eller eldre, ter seg gjerne med sterk brå hovudverk, stiv nakke som ter seg etter om lag 6 timar, kvalme/oppkast, uklar sinnstilstand og andre teikn på hjerneskade etter kor stor blødinga er; ekstra hjerneskade kan koma etter 4–12 dagar pga sviktande blodforsyning til hjernevev; kan utløysast av tunge tak, samleie e a; i spinalvæska er det blod og væska er gul etter sentrifugering; jf berry aneurysm, aneurysma intracraniale; EN subarachnoid hemorrhage; BM subaraknoidalblødning. Kilde: Norsk medisinsk ordbok.)

(Anm: PTSD og ikke traume øker selvmordsrisiko (reuters.com 5.3.2009).)

Antidepressiva kan skade menns sædceller (DNA)

Anti-depressants can damage men's sperm (Antidepressiva kan skade menns spermie)
chicagotribune.com 12.6.2009
Add anti-depressants to the list of substances that can damage men’s sperm and potentially impair their fertility.

In a new study, New York researchers report that as many as half of men taking the anti-depressant paroxetine (brand names, Seroxat and Paxil) have higher levels of sperm fragmentation.

The study was published online today by the journal Fertility & Sterility.

“It’s fairly well known that SSRI anti-depressants negatively impact erectile function and ejaculation. This study goes on step further, demonstrating that they can cause a major increase in genetic damage to sperm,” said Dr. Peter Schlegel, the study’s senior author and professor of reproductive medicine at Weill Cornell Medical College in New York.

“Although this study doesn’t look directly at fertility, we can infer that as many as half of men taking SSRIs have a reduced ability to conceive. These men should talk with their physicians about their treatment options,” he added. (...)

Dr. Cigdem Tanrikut speculated that the anti-depressant caused mens’ sperm to slow down as it makes its way through the male reproductive tract. Sperm gets “hung up,” she said in a statement, allowing it to age and become damaged.

The amount, concentration and motility of sperm were not significantly changed by the medication.

Though men may not know it, sperm can be damaged by various substances, including smoking, alcohol, heat, anabolic steroids, drug abuse, sexually transmitted diseases and some environmental exposures. (...)

Adverse effect of paroxetine on sperm (Uheldig virkning av Seroxat (paroxetine) på sædceller)
Fertility and Sterility (American Society for Reproductive Medicine)
published online 10 June 2009.
Objective
To assess the effects of a selective serotonin reuptake inhibitor on semen parameters. (...)

Patient(s)
Thirty-five healthy male volunteers, 18–65 years old.
Intervention(s)
Paroxetine administration for 5 weeks. (...)

Conclusion(s)
In men with normal semen parameters, paroxetine induced abnormal sperm DNA fragmentation in a significant proportion of subjects, without a measurable effect on semen parameters. The fertility potential of a substantial number of men on paroxetine may be adversely affected by these changes in sperm DNA integrity. (...)

The Bad Daddy Factor
miller-mccune.com 10.12.2010
Drinking, smoking, taking prescription meds or failing to eat a balanced diet can influence the health of men’s future children. (...)

Drugs can also interfere with sperm transport. A 2009 study revealed that a standard dose of paroxetine — the active drug in the antidepressant marketed as Paxil — causes a fivefold increase in the number of men who show evidence of “sperm fragmentation,” which can increase the chances of miscarriage. Researchers have known that certain antidepressants can influence ejaculatory response; it turns out that they seem to slow the transportation of sperm through the male reproductive system, causing the cells to age prematurely. “Sperm are being damaged because they’re not traveling properly through the body,” says Peter Schlegel, who led the study and is a urologist at New York’s Weill Cornell Medical College. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Anti-Depressant-Associated Changes In Semen Parameters
medpagetoday.com 28.11.2008
SAN FRANCISCO, CA, USA (UroToday.com) - The authors previously reported an effect of antidepressants on semen parameters. The current study was designed to assess/confirm their prior report of the effects of an SSRI, paroxetine (Paxil), on semen parameters. (...)

As opposed to prior report, semen parameters (volume, concentration, motility, morphology) were not significantly altered during SSRI treatment. However, mean DNA fragmentation TUNEL score was significantly higher on SSRI (30.3%) versus baseline (13.8%). Multivariate logistic regression, correcting for age and body mass index, confirmed that SSRI treatment was significantly correlated with increased DNA fragmentation Up to 35% of men noted significant changes in erectile function and up to 47% of subjects reported ejaculatory difficulties while on paroxetine. (...)

Svårare bli pappa med antidepressiva
sr.se 26.9.2008
(...) Antidepressiva läkemedel kan göra det svårare för män att få barn. Det tycks bero på att spermierna drabbas av skador i sitt DNA, visar en första, mindre undersökning från Cornell Medical Centre i New York. (...)

Paxil could make men infertile, researchers suggest (Seroxat kan gjøre menn sterile)
pharmatimes.com 25.9.2008
US scientists have claimed that one of the most commonly used selective serotonin re-uptake inhibitors, GlaxoSmithKline's Seroxat/Paxil, causes serious DNA damage in sperm cells, according to the report in New Scientist. (...)

Paxil could make men infertile, researchers suggest
pharmatimes.com 25.9.2008
US scientists have claimed that one of the most commonly used selective serotonin re-uptake inhibitors, GlaxoSmithKline's Seroxat/Paxil, causes serious DNA damage in sperm cells, according to the report in New Scientist. (...)

Antidepressants may damage male fertility: study (Antidepressiva kan skade menns fruktbarhet, ifølge studie)
reuters.com 24.9.2008
LONDON (Reuters) - Common antidepressant drugs may reduce some men's fertility by damaging the DNA in their sperm, according to scientists.

A study of 35 healthy men given paroxetine -- sold as Paxil or Seroxat by GlaxoSmithKline -- found that, on average, the proportion of sperm cells with fragmented DNA rose from 13.8 percent before treatment to 30.3 percent after just four weeks.

Similar levels of sperm DNA damage have been linked to problems with embryo viability in couples trying to have children. (...)

Allan Pacey, Senior Lecturer in Andrology at the University of Sheffield, said the apparent increase in sperm DNA damage was "alarming," although he noted the level at which damage becomes clinically significant was open to debate. (...)

Being Overweight Does Not Result In Decreased Sperm Production, Study Shows
sciencedaily.com 17.6.2008
(...) Santoro and her coworkers plan to further study a trend they saw toward reduced sperm motility in the six men who were taking an antidepressant in the selective serotonin reuptake inhibitor (SSRI) class. This class of drugs includes Prozac, Celexa, Lexapro, Paxil and Zoloft.

“We know that SSRIs affect sex drive, but there aren’t much data on their effect on fertility,” she said.

The results will be presented at The Endocrine Society’s 90th Annual Meeting in San Francisco. (...)

Antidepressants may make men infertile (Antidepressiva kan gjøre menn sterile)
guardian.co.uk 24.10.2006
Bestselling antidepressant drugs may be making some men infertile, research reported yesterday suggested.

The warning follows a study of two men at Cornell Medical Centre in New York whose sperm counts dropped to almost zero while taking the drugs but recovered to healthy levels whenever their medication was suspended.

The men were tested over a two-year period while being treated with the selective serotonin reuptake inhibitors (SSRIs) Citalopram (Cipramil) or Sertraline (Lustral), which belong to the same class of drugs as Prozac and Seroxat, Britain's biggest selling antidepressants. (...)

"These were men with normal sperm counts that went to nearly zero when they were on these antidepressants but returned to normal when they were off them," Prof Schlegel said.

"It's a dramatic effect and it has never been described before. We believe that while it has had a profound effect on these two men, it could be having a significant but more subtle effect on many more." (...)

Antidepressants Linked to Male Infertility
newsinferno.com 24.10.2006
Researchers at New York’s Cornell Medical Center have found a major correlation between use of antidepressants and sperm count. Men who take selective serotonin reuptake inhibitors (SSRIs) are being urged to consult closely with their doctors in order to determine a proper course of action in light of the new study, the first of its kind. Cornell’s Peter Schlegel announced the results this week at the 62nd annual meeting of the American Society for Reproductive Medicine (ASRM) in New Orleans. (...)

Dr. Schlegel believes that the problem may be connected to damage of the nerves in the vas deferens, the tube trusted with the task of delivering sperm to semen just before ejaculation. For male SSRI patients who may be considering starting or continuing a family, the results may have major ramifications. (...)

(Anm: vas deferens; ductus deferens; jf ev kongenital bilateralt manglande vas deferens EN vas deferens. Kilde: Norsk medisinsk ordbok.)

(Anm: vas deferens; wikipedia.org.)

Prozac is linked to low sperm count (Prozac linket til dårlig sædkvalitet)
timesonline.co.uk 24.10.2006
ANTIDEPRESSANT drugs could lower men’s sperm count, the first investigation of their effect on male fertility has found. (...)

Kellers resultater for Seroxat bestridt av leger, FDA

Keller's findings on Paxil disputed by doctors, FDA (Kellers resultater for Seroxat bestridt av leger, FDA)
browndailyherald.com 23.9.2008 (The Brown Daily Herald, Inc.)
Controversial study may have hid suicide links

Among the reasons Sen. Charles Grassley, R-Iowa, has targeted Professor of Psychiatry and Human Behavior Martin Keller in his scrutiny of conflicts of interest in clinical research is Keller's authorship of a controversial study of the antidepressant Paxil in children.

The study and its authors have been fiercely criticized in medical journals for allegedly misrepresenting data, suppressing information linking the drug to suicidal tendencies and reaching a conclusion unsupported by the relevant data.

The Herald contacted Keller several times starting Sept. 10, but he said he was unavailable for comment before press time. (...)

Senator targets professor's ties to big pharma (Senator angriper professors bånd til legemiddelindustrien)
browndailyherald.com 23.9.2008 (The Brown Daily Herald, Inc.)
Psych chair told to disclose payments

Investigators from the U.S. Senate Finance Committee are scrutinizing Brown over disclosure of conflicts of interest in clinical research, Provost David Kertzer '69 P'95 P'98 confirmed Thursday.

Though University spokespeople would not comment on the details of a letter of inquiry from ranking committee member Sen. Charles Grassley, R-Iowa, a source familiar with the investigation has confirmed that the letter names Professor of Psychiatry and Human Behavior Martin Keller, the chairman of the psychiatry department at the Alpert Medical School.

Grassley has sent letters to more than 20 academic institutions asking that specific researchers disclose all financial ties to drug companies. (...)

Diverse artikler

Georgia lawyer says Paxil made client rob Bank of America (Georgia-advokater sier Seroxat (Paxil) gjorde at klienten ranet Bank of America)
socialenterpriselive.com 24.1.2012
A lawyer for a man accused of robbing a Bank of America (NYSE: BAC) branch in Augusta says his client was a victim of “involuntary intoxication” at the time due to the Paxil anti-depressant he was taking, reports the Augusta Chronicle.

Assistant District Attorney Hank Syms isn’t buying lawyer Peter Johnson’s claims, and “waved away any claim” of such intoxication when the robbery occurred in July 2010, the newspaper reported. Syms said about one-third of clients that make guilty pleas say they are affected by some form of medication, but added he’s never heard the Paxil defense because most lawyers know better than to claim it. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Paxil (paroxetine HCl) tablets, oral solution and Paxil CR tablets
fda.gov 2011 (July)
Summary View

CONTRAINDICATIONS
Do not start PAXIL in a patient who is being treated with a reversible MAOI such as linezolid or methylene blue because of an increased risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions (see WARNINGS).
Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).

PRECAUTIONS

Drug Interactions
new pimezole drug interaction information added (...)

Paroxetine is associated with malformation during pregnancy (Paroxetine (Seroxat; Paxil) er knyttet til misdannelser under svangerskapet)
BMJ 2011; 343:d5060 (10 August)
In their clinical review of the diagnosis and management of premenstrual disorders O’Brien and colleagues state¹: “Obviously, some patients may become pregnant while taking SSRIs [selective serotonin reuptake inhibitors] and these drugs have not been shown to be teratogenic” with a reference to an article reviewing the adverse effects of SSRIs in pregnancy.² This is incorrect and is inconsistent not only with the reference provided but also with both the label (black box warning and the pregnancy category D labelling) and the wider literature. Tuccori et al in fact state:

“Paroxetine has been associated with significant risks of major malformation, particularly cardiac defects, when used during pregnancy.

“Significant associations between maternal exposure to SSRIs and both persistent pulmonary hypertension of the newborn and a self-limiting neonatal behavioral syndrome have been reported in a number of recent original studies and meta-analyses.”²

They correctly conclude: “The available evidence suggests that SSRIs and other serotonergic/noradrenergic antidepressants should be used with caution during pregnancy, with careful follow-up of infants exposed to these agents in utero.”

Evidence shows SSRIs to be teratogenic in early pregnancy.³ Concerns about the effects on child development are emerging with a recent signal of a potential link with autistic spectrum disorder.^{4 5} This is important information for clinicians and patients to be aware of when use is in women of reproductive age. Women need to be warned of these potential adverse events when these medicines are prescribed. (...)

Heat Spikes Death Risk from Drugs
healthland.time.com 22.7.2011 (Time)
With relentless heat enveloping much of the nation, no one, it seems is spared. That includes a group at especially high risk of harm from high temperatures: drug users, both therapeutic and recreational, particularly those who take stimulants like cocaine, methamphetamine and Ritalin or antidepressants and other psychiatric medications.

One study found that for every week that the temperature exceeds 75 degrees Fahrenheit, New York City will experience two extra cocaine-related deaths. And, as the temperature climbs, the number of deaths leaps proportionally. A week like this with temperatures in the 90's and possibly 100's might tally 4-7 extra cocaine deaths in New York City alone.

“High doses of stimulants can produce extremely high body temperatures,” says Zheng-Xiong Xi, a researcher at the National Institute on Drug Abuse. And extremely high body temperatures can kill. (...)

(Anm: Ambient temperature and risk of death from accidental drug overdose in New York City, 1990-2006. Addiction. 2010 June; 105(6): 1049–1054. (June 1).)

Antidepressants Taken During Pregnancy And Birth Defects (Antidepressiva brukt under svangerskapet og fødselsdefekter)
healthnewsdigest.com 6.6.2011
While this subject is by no means a new one, the resurgence of TV commercials touting the relevant expertise of various plaintiff's attorneys inspired this article.

(HealthNewsDigest.com) - Ever since the Thalidomide catastrophe of the late 1950s, whereby a sedative drug used during pregnancy for morning sickness—largely in Europe—produced thousands of birth defects, the entire notion of taking drugs during pregnancy was considered beyond the pale for most women. At the time of its introduction into the marketplace, it was assumed (based on what, no one can say) that the placenta provided an effective barrier to exogenous substances. Some accounts suggest that even a single dose of Thalidomide was enough to cause significant damage. (...)

As to linking antidepressant drugs to birth defects, the landmark case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania. On October 13, 2009, the jury found for the plaintiffs, concluding that Glaxo failed to properly warn doctors and pregnant users of Paxil's risk and ordered the company to pay $2.5 million to the family of Lyam Kilker—born with severe heart problems—whose mother took Paxil during her pregnancy.

The case was presented as a classical "failure to warn," a charge which has some credibility. Still, one wonders what sort of doctor would prescribe a powerful drug to a pregnant woman? It is difficult to imagine any doctor not discussing the generic risks (even if specific risks were unknown at the time) of taking drugs while pregnant. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Common drug combo increases diabetes risk (Vanlig kombinasjon av legemidler øker risikoen for diabetes)
newscientist 27.5.2011
A combination of two common drugs – one an antidepressant, the other used to lower blood cholesterol – may put people at risk of developing diabetes. This unexpected finding shows the benefits of data mining to discover hidden hazards lurking in our medicine cabinets.

Interactions between drugs can be hazardous or even fatal. When a particular combination of drugs is known to be dangerous a warning appears on the drugs' labelling, but there are many potential hazards that are not yet known about.

To look for drug combinations that might trigger diabetes, Nicholas Tatonetti and Russ Altman of Stanford University in California turned to a database called the Adverse Event Reporting System (AERS), run by the US Food and Drug Administration (FDA).

AERS contains reports from doctors whose patients have experienced drug side effects, but some researchers dismiss it as being too "noisy" to yield useful insights. One problem is that many adverse drug reactions never get reported. "There's a pretty big threshold for a physician to decide to submit a report to the FDA," Tatonetti explains.

And when a drug's hazards become well known, the database gets flooded with "me too" reports – for instance, AERS contains more than 70,000 reports about Vioxx, an anti-inflammatory painkiller that was withdrawn from sale in 2004 after being linked to deaths from heart attacks and stroke. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: Detecting Drug Interactions From Adverse-Event Reports: Interaction Between Paroxetine and Pravastatin Increases Blood Glucose Levels Clinical Pharmacology & Therapeutics 2011 (25 May).)

Stan Kutcher involved in controversial drug test
thecoast.ca 28.4.2011
Lberal candidate for Halifax co-authored problematic Paxil study

Stan Kutcher, the Liberal candidate for Halifax in Monday’s federal election, is running on his expertise as a doctor.

“I have a lot of experience in the health field,” says Kutcher, “in multiple areas: as a clinician, as a researcher, as associate dean of our medical school and in my work globally in my work with the World Health Organization, as someone who has worked to establish a number of national health institutions.”

But Kutcher’s experience as a clinician and researcher includes his involvement in a controversial drug test known as the Paxil 329 study, which was the subject of multiple lawsuits and explosive allegations of wrongdoing by researchers, and which ultimately changed the way medical research is conducted.

That study started in 1992, when Martin Keller, then the chair of the Psychiatry department at Brown University, proposed to the drug company SmithKline Beechman a study of the use of Paxil for the treatment of adolescent depression. In 2000, SmithKline Beechman merged with Glaxo Wellcome to become GlaxoSmithKline.

The drug trials took place between 1994 and 1997 at 12 research centres across North America, including the Dalhousie Medical School, where Kutcher oversaw the trials. It was a typical “double blind” study, with half the participants taking Paxil, and half taking a placebo. The results were published in 2001, with Kutcher as co-author.

But as documents later made public through the lawsuits demonstrate, the initial outcome measures in the study showed that there was no difference in therapeutic benefits between Paxil and the placebo, but those measures were changed to give Paxil a more favourable result.

“They essentially distorted the outcome measures, and essentially lied,” says Alison Bass, a former science reporter with the Boston *Globe* who broke the story and went on to write *Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial*, which examines the Paxil 329 study. “They also omitted information about adolescents who became suicidal on Paxil and withdrew from the study. And they miscoded those teenagers---they said they were non-compliant when in fact they had been withdrawn from the study because they became suicidal.”

Only in 2003, when a secretary at Brown leaked information to Bass, did the problems with the study became public. Afterwards, New York state attorney general Eliot Spitzer sued GlaxoSmithKline for fraud; that suit was settled out of court, but together with separate suits filed in Canada and California, hundreds of internal GSK documents were released. In Britain, the Committee on the Safety of Medicine found that the incidence of suicidal thoughts in the Paxil group was double that of the placebo group. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Paxil May Increase Suicide Risk for Patients with Major Depression: Study
aboutlawsuits.com 11.4.2011
The antidepressant Paxil may increase the risk of suicide among individuals who are already suffering from major depressive disorders, according to new research.

A study published in the Journal of Clinical Psychiatry, which was funded by the drug’s maker, GlaxoSmithKline, found that some individuals taking Paxil were more likely to consider suicide than individuals who were given a placebo. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Antidepressants Linked to Thicker Arteries
sciencedaily.com 11.4.2011
ScienceDaily (Apr. 2, 2011) — Antidepressant use has been linked to thicker arteries, possibly contributing to the risk of heart disease and stroke, in a study of twin veterans. The data is being presented on April 5 at the American College of Cardiology meeting in New Orleans.

Depression can heighten the risk for heart disease, but the effect of antidepressant use revealed by the study is separate and independent from depression itself, says first author Amit Shah, MD, a cardiology fellow at Emory University School of Medicine. The data suggest that antidepressants may combine with depression for a negative effect on blood vessels, he says. Shah is a researcher working with Viola Vaccarino, MD, PhD, chair of the Department of Epidemiology at Emory's Rollins School of Public Health.

The study included 513 middle-aged male twins who both served in the U.S. military during the Vietnam War. Twins are genetically the same but may be different when it comes to other risk factors such as diet, smoking and exercise, so studying them is a good way to distill out the effects of genetics, Shah says.

Researchers measured carotid intima-media thickness -- the thickness of the lining of the main arteries in the neck -- by ultrasound. Among the 59 pairs of twins where only one brother took antidepressants, the one taking the drugs tended to have higher carotid intima-media thickness (IMT), even when standard heart disease risk factors were taken into account. The effect was seen both in twins with or without a previous heart attack or stroke. A higher level of depressive symptoms was associated with higher IMT only in those taking antidepressants. (...)

Marathon runner remembers his daughter as race nears
2.scnow.com 18.2.2011
(...) One day in 2002, she came to her parents with some concerns.

“Korinne came to her mother and I and said that she's been going through some mood swings and she would feel happy one day, sad the next day, kind of back and forth,” Kevin said.

Korinne began seeing a counselor and was recommended by a doctor to go on Paxil - an anti-depressant.

Ten days later the teen did the unexpected.

“I picked her up from school, brought her home, dropped her off and returned to work, and about an hour after that occurred she shot herself,” said Kevin.

Korinne died one week later, but in that week her parents decided to make her an organ donor. The very night of her death she saved another man's life - a man that she'd never even met. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Paxil Lawsuits -Will They Ever End?
.mypaxillawsuit.com/ 16.1.2011
Posted on January 16, 2011 by The Food and Drug Administration has evaluated two reports establishing that women prescribed and who took the antidepressant, Paxil, during the first trimester of their pregnancy had 1 1/2 to two times risk of producing children with a heart defect than those who took other types of antidepressants. Because of this, FDA counseled pregnant women and their doctors of this risk. They also placed Paxil on Category D, the second top class of drugs with risk of birth defects. (...)

The five-year legal action chronicle against GlaxoSmithKline involved many types of cases. Other lawsuits filed were on the increase risk of suicide behaviors among children taking Paxil and those about the increase risk of developing dependence to the drug.

Evidences have been presented that the company deliberately withheld information regarding the withdrawal symptoms and serious side effects the drug has for pregnant women in their first trimester of pregnancy and to children taking the medication. (...)

Questions about Antidepressants and Pregnancy
lawyersandsettlements.com 14.1.2011
There’s a lot in the news about pregnancy and antidepressants (SSRI’s in particular—and especially Paxil, which has a Category D rating by the FDA). And we get a lot of comments and emails from readers who are either looking for information about SSRI drugs and pregnancy—or who share their stories about negative side effects they’ve experienced while taking antidepressants. (...)

Ricky Williams' Criticism of Coach Tony Sparano Caps Off a Long List of Ricky Williams Oddities
browardpalmbeach.com 4.1.2011
(...) Take the pot smoking. Williams admitted early in his time with the Dolphins to being diagnosed with a social anxiety disorder, which attributed to his shy demeanor in the locker room. He briefly served as a spokesman for the drug Paxil. But when asked if pot or Paxil is better, he had a quick answer: "Marijuana is ten times better for me than Paxil."

Truth is, he's right. Paxil has a list of side effects that'll fill one of those pamphlets they stuff into the prescription box. It causes birth defects in pregnant women and increases suicidal tendencies of teens. Worse, it's maker, GlaxoSmithKline, has been accused of mixing up pills, meaning takers of Paxil may be getting double doses or some other drug entirely. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Whistleblower Alleges Problems with Paxil Doses (Varsler påstår det var problemer med Seroxat-doser)
lawyersandsettlements.com 9.1.2011
Boston, MA: With some pregnant women concerned about Paxil side effects and what consequences potential Paxil birth defects could have on their infants, news that some Paxil shipments contained incorrect doses might be a cause for alarm. Although those shipments occurred in the past—they were recently discussed in a 60 Minutes news report—they could add to concern that drug companies are more interested in profit than patient safety. Some women are already concerned that Paxil side effects caused birth defects in their newborn babies. (...)

Barn med lav fødselsvekt mer psykisk syke
dagbladet.no 20.12.2010
Angstlidelser og ADHD vanligst.

Barn med lav fødselsvekt har større risiko for psykisk sykdom i 20-årene enn jevngamle med normal fødselsvekt, ifølge en studie utført ved NTNU.

Blant de undersøkte for tidlig fødte barna med lav fødselsvekt hadde én av tre fått en diagnose som omfattet en psykisk lidelse ved 20 års alder.

Hos jevngamle som hadde hatt normal fødselsvekt, var dette tilfelle for under én av ti. Hos personer som ble født til termin, men med lav fødselsvekt, forekom psykisk sykdom hos hver fjerde da de var 20 år gamle, skriver Dagens Medisin. (...)

Duloxetine-related tardive dystonia and tardive dyskinesia: a case report
Gen Hosp Psychiatry. 2010 Nov-Dec;32(6):646.e9-646.e11. Epub 2010 Jun 3.
Tardive dyskinesia and tardive dystonia are caused by dopamine receptor blocking agents, mostly antipsychotics and sometimes antidepressants or calcium channel blockers. Duloxetine-related tardive syndrome is rarely reported in the literature. We report one case of tardive dystonia and tardive dyskinesia occurring in a 58-year-old female with major depressive disorder, who developed distressing oral dyskinesia, mandibular dystonia with trismus and dystonia over left neck after treatment of duloxetine (30-60 mg per day) for 18 months. Despite discontinuation of duloxetine, she only obtained partial remission. Even though this association has been rarely reported, duloxetine may pose a potential risk of inducing tardive syndrome. Clinicians should cautiously detect early signs of movement abnormality when prescribing antidepressants. (...)

Yale Paxil Study Alleged Promotional Scheme
newsomelaw.comn 15.12.2010
A Yale Daily News article explains that a “School of Medicine faculty member has been accused of signing her name to a ghostwritten study” for a report on the antidepressant, Paxil. According to the news article, this is “a practice that many believe amounts to plagiarism and undermines scientific integrity.”

The Yale Daily News goes on to explain that “The nonprofit watchdog Project on Government Oversight (POGO) claims that School of Medicine associate professor Kimberly Yonkers signed her name to work that was not her own in a 2003 report.” POGO contacted the National Institutes of Health, which funds some of Yonkers’ research, “identifying about four separate cases of alleged ghostwriting,” the Daily News alleges.

According to the article, “One of these was Yonkers’ study, which POGO claims was part of a promotion scheme by pharmaceutical company GlaxoSmithKline to increase Paxil sales.” The Yale newspaper explains that Yonkers denied these accusations, saying she was “extensively involved in writing and editing the report.” (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Yale Medical Professor Accused of Ghostwriting Paxil Side Effects Study
lawyersandsettlements.com 14.12.2010
New Haven, CT: A professor at Yale's School of Medicine has been accused of signing her name to a ghostwritten study on Paxil side effects, the Yale Daily News reports.

The Project on Government Oversight (POGO), a nonprofit watchdog, claims that associate professor Kimberly Yonkers signed her name to work that was not hers in a 2003 report on Paxil, an antidepressant drug, the news source said.

POGO claims that Yonkers's alleged ghostwritten study was a part of a promotional scheme by GlaxoSmithKline to increase the sales of Paxil. Yonkers, however, claims she was very involved in the report's writing and editing, according to the news provider. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Report: Paxil, Other Drugs May Be Responsible for High Army Suicide Rate (Rapport: Seroxat (Paxil) og andre legemidler kan være ansvarlig for det høye antall selvmord innen militæret)
lawyersandsettlements.com 9.11.2010
Washington, D.C.: A recent report from the United States Military suggests that the high suicide rate among American troops may be one of many Paxil side effects, according to the Epoch Times.

Washington, D.C.: A recent report from the United States Military suggests that the high suicide rate among American troops may be one of many Paxil side effects, according to the Epoch Times.

According to the report, in 2009 the Army saw 239 suicides and 1,713 suicide attempts. Additionally, there were 146 deaths due to drug overdoses or high-risk behavior.

The report also found high rates of use of psychoactive medication like Paxil, with the number of troops aged 18 to 34 using such drugs rising by 85 percent since 2003. In total, one out of every six troops currently uses psychoactive medications.

The news source reports that Senator Jim Webb of Virginia, who served as Secretary of the Navy in the 1980s, said that this high rate of use is "pretty astounding and also very troubling" during a congressional hearing.

"I feel flat-out that psychiatrists are directly responsible for deaths in our military, for some of these suicides. I think it's criminal, what they are doing," Retired Colonel Bart Billings, a former Army psychologist, told the Marine Times.

READ MORE [ PAXIL BIRTH DEFECTS ARTICLES ] (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Fresno Mom In Child Drowning Case Sentenced (Fresno-mor dømt for drukning av sitt barn)
kmph.com 18.10.2010
A Fresno mother, who admitted to drowning her seven–month–old daughter, was sentenced on Monday.

Lisa Brown was sentenced to 15 years in prison for drowning her baby daughter Jillian.

Brown pleaded no contest in the case back in August. According to court records, Brown told several investigators her daughter was "possessed" on Christmas Eve of 2007.

Brown fortalte detektiver at det var djevelen som ba henne om å gjøre det. Hun fortalte også detektiver at hun selvmedisinerte seg med marihuana, og hadde tatt antidepressivaet Seroxat (Paxil). (Following the incident, Brown told detectives the devil made her do it. She also told detectives she had been self-medicating with marijuana, and had taken the anti-depressant, Paxil.)

Stay with KMPH and KMPH.com as we continue to follow this story. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

He Killed His Own Son While on Paxil (Han drepte sin sønn mens han tok Seroxat (Paxil))
lawyersandsettlements.com 22.10.2010
Huntsville, ON: Anyone who ever felt that antidepressants are generally safe need only know the story of David Carmichael, a Canadian who lost his son to Paxil side effects. That's because Carmichael, while taking Paxil, strangled his 11-year-old son in a hotel room. It was 2004, and Carmichael was severely depressed and taking Paxil at the time. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Paxil Plaintiff Settles Birth Defects Lawsuit (Seroxat-saksøker forliker fødselsdefekt-søksmålsøksmål)
lawyersandsettlements.com 20.10.2010
Watertown, SD: A woman who recently settled her Paxil birth defects lawsuit ended a legal ordeal that began with the 2004 death of her newborn son. The woman's Paxil lawsuit alleged her son suffered from Paxil birth defects, including persistent pulmonary hypertension of the newborn (PPHN). (...)

READ MORE [ PAXIL ARTICLES ] (...)

Doctor: Paxil "Especially Notorious" for Causing Withdrawal
lawyersandsettlements.com 9.10.2010
Atlanta, GA: There are a number of Paxil side effects associated with the antidepressant, and some patients continue to experience these effects even after discontinuing use of the drug. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Seminars to focus on hazards of prescription drugs (Seminar fokuserer på farer ved reseptbelagte legemidler)
cottagecountrynow.ca 30.9.2010
SOUTH MUSKOKA - Few people know the dangers of prescription medication better than David Carmichael.

In 2004, Carmichael killed his 11-year-old son in what he believes was a psychosis brought on by anti-depression medication. Carmichael was found to be not criminally responsible for his actions and received an absolute discharge.

Now the Huntsville resident has made it his life’s work to try to prevent something similar from happening to anyone else. (...)

“There are adverse side effects of psychotropic, or mind-altering drugs, that many doctors aren’t even aware of,” he said. “They’re starting to find out that some of these adverse side effects are a lot more prevalent than they thought.”

Carmichael said he has seen the worst of those effects first-hand.

“In 2003 I had my first major depression and was prescribed 40 milligrams of Paxil,” he said. “After about eight months on Paxil, I weaned myself off of the drug because it has some uncomfortable side effects.”

Carmichael said for several months after coming off the drug he entered a “manic phase,” sleeping little as he became obsessed with making business deals.

Everything came crashing down in 2004 when Carmichael relapsed into a deep depression. Without consulting his doctor, Carmichael went back on Paxil, but this time things quickly spun out of control. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Penile Amputation: Nightmare Side Effect (Penisamputasjon: marerittaktig bivirkning)
blogs.forbes.com 23.9.2010
When you wind up in the emergency room, do tell your doctor about every medicine that you are taking. Case in point, a recent medical journal report I found while researching a widely used psychiatric drug.

WARNING: The included link contains graphic medical photographs that may not be safe for work.

“Penile Amputation After Trazodone-Induced Priapism: A Case Report,” was published in the Primary Care Companion to The Journal of Clinical Psychiatry this year, and recounts the case of a 35-year-old man who was prescribed trazodone, an antidepressant that predates Prozac and Paxil and is still the #12 most-used psychiatric drug, by a psychiatrist to treat sleep problems. The article was written by doctors at hospitals in Germany and Belgium. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

(Anm: - priapisme - langvarig ereksjon Hva er priapisme? Priapisme er langvarig og smertefull ereksjon. Ereksjonen har gjerne vedvart i noen timer. Etter hvert vil det utvikle seg smerter i penis og mellomkjøttet (området mellom penis og endetarmsåpningen). (nhi.no).)

(Anm: Penile Amputation After Trazodone-Induced Priapism: A Case Report. Prim Care Companion J Clin Psychiatry. n-volume">12(2): PCC.09l00816.)

Files Indicate Settlement in Paxil Lawsuit (Dokumenter indikerer forlik i Seroxat-søksmål)
abcnews.go.com 19.7.2010
Agreement reached in SD woman's lawsuit against pharmaceutical company over son's death (Enighet er oppnådd i et søksmål mot et legemiddelfirma grunnet sønnens død)

A settlement has been reached in a lawsuit filed against a pharmaceutical company by a Watertown woman who linked her prescribed use of Paxil to the death of her infant son, according to court files.

Jennifer Berg of Watertown sued SmithKline Beecham, doing business as GlaxoSmithKline, in October 2007. The complaint said Nathan Berg died in 2004 because of a heart disorder caused by her use of the antidepressant Paxil while she was pregnant.

The federal court lawsuit sought unspecified damages from the company for failing to warn of a link between the two. Letters from her attorneys to the presiding judge indicate there's a settlement. No settlement documents have been filed in court. (...)

RESIGNED TO DIE
chickashanews.com 19.7.2010 (Karen Brady The Express-Star )
Ronson Bush confessed to killing his best friend; now, he says, the responsible thing to do is die.

— Confessed killer Ronson Bush lives in an 11 by 15-foot cell on Death Row at the Oklahoma State Penitentiary in McAlester, Okla. (...)

Drugs and alcohol
Earlier, while still at the hospital, Bush was given the antidepressant Celexa, a class of drug known as SSRIs, or selective serotonin reuptake inhibitors.

Celexa is a drug that some health professionals say can cause individuals taking it to experience a loss of caring that can unleash dangerous actions.

Psychologist Dr. Gail Poyner, an expert witness who testified in Bush's defense, says, "Research has consistently shown that in certain people, SSRIs can cause adverse reactions that include suicide, violence, even homicide.

"Studies published in respected scientific journals are drawing attention to the very real dangers of SSRIs - especially in individuals whose brains are missing certain enzymes needed to metabolize these drugs. For those people, the build up of SSRIs can lead to devastating, out of character behavior."

Poyner also said it is very common for individuals who commit SSRI-related crimes not to remember their own actions while under the influence of the drug.

Bush believes the Celexa in his system had much to do with the tragic events of Dec. 22, 2008.

"It kills me what happened; it just does not make sense," he says. "I've been drunk and high before and I've never had a violent thought. The only factor that's different is the Celexa."

In addition, over the course of the evening, Bush consumed a pint of vodka, telling Harrington he felt “weird” and “numb to everything.” (...)

Fraudster's champagne life on bail
thestar.co.uk 12.7.2010
A BUSINESSMAN fleeced his customers out of thousands of pounds, spent their cash living the high life in hotel rooms, drinking champagne and visiting the opera, then went on the run, a court heard. (...)

He claimed his medication Seroxat - prescribed for OCD, depression and anxiety - led to mood swings and, during his manic periods, he became reckless. (...)

US close: Google disappoints, Goldman pays up and BP caps leak
sharecast.com 15.7.2010
(...) Drugs firm GlaxoSmithKline expects to record legal costs for the second quarter of 2010 of £1.57bn. These relate to an investigation by the US Government into the company's former manufacturing site at Cidra, Puerto Rico; product liability and anti-trust litigation relating to Paxil (paroxetine), and product liability cases regarding Avandia (rosiglitazone) and other products. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Those Mysterious Army Deaths: An Update (De mystiske dødsfall i hæren: En oppdatering)
blogs.seattleweekly.com 25.6.2010
A Seattle Weekly cover story last December about the Camp Liberty, Iraq, massacre of U.S. soldiers by John Russell, a deranged Fort Lewis sergeant, also focused on other puzzling non-combat deaths, including soldiers dying in their sleep. Now Georgia author Cilla McCain and San Diego neurologist Fred Baughman, who helped us with the cover story, have probed further into the mysterious body count. In a column today at Huffington Post, McCain reports that "if you conduct an internet search with the phrase 'soldier found dead' the results are staggering. Narrow it down even further by including the phrase 'unexplained' and you will begin to get a glimpse of what some would call an epidemic." (...)

Dr. Baughman, a critic on the use of anti-psychotic drugs, undertook a study of the soldier deaths and determined "sudden cardiac death" to be the cause. As he said in a press release last month, "All were diagnosed with PTSD. All seemed 'normal' when they went to bed. And all were on Seroquel (an antipsychotic) Paxil (an antidepressant) and Klonopin (a benzodiazepine). They were not comatose and unarousable," as in many suicides, he said. "These were sudden cardiac deaths."

The military doesn't necessarily agree, but the Pentagon is failing its mission to properly investigate such deaths and determine the causes, whatever they may be, McCain writes:

Between the VA medical doctors and psychiatrists Andrew was going to for help, none tried to assess the effectiveness of these drugs on his PTSD symptoms. They just kept increasing the dosage as if he were a guinea pig in some twisted lab experiment. Whether sudden cardiac death, polypharmacy, or suicide, a prescription tracking system could be a major step toward preventing tragedy. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Dying In Their Sleep: The Invisible Plague Attacking U.S. Soldiers (Dør under søvn: Den usynlige farsott som angriper amerikanske soldater)
huffingtonpost.com 23.6.2010
While doing research for the book Murder In Baker Company, I came to know many military family members from the support group "Home of the Brave." The group's goal is to help one another gain information and justice in the noncombat related deaths of their loved ones. According to the Department of Defense nearly 1 out of 4 fatalities in the military are noncombat related. (...)

Struggling with PTSD compounded by grief over the death of his brother, Andrew sought help from VA doctors. Their first line of defense was to prescribe him 20 mg. of Paxil, 4 mg of Klonopin and 50 mg of Seroquel. These medications helped at first, but later proved ineffective. Instead of changing the course of treatment, the doctors responded by continually increasing his dosage until the Seroquel alone reached a whopping 1600 mg per day. Within weeks of Andrew's death, three more young West Virginia veterans died while being treated for PTSD with the same drugs, prompting Stan and Shirley White to begin a mission to find out what the deaths have in common. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Stephen Foley: The best prescription for pharma firms (Stephen Foley: Den beste forskrivning for legemiddelfirmaer)
independent.co.uk 12.6.2010
US Outlook: It was a legal battering in the US over the depression medicine Paxil that bounced GlaxoSmithKline into setting up an online register of all its clinical trial data, regardless of whether it had pushed to have the results of a study published in a medical journal. The company had been accused of burying studies which showed the medicine was less effective or more dangerous. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Antidepressants during pregnancy increase risk of sponaneous abortion, study finds (Antidepressiva i løpet av svangerskapet øker risikoen for spontanaborter, ifølge studie)
latimes.com 31.5.2010
(...) In the new study, Dr. Anick Berard, director of the University of Montreal's Research Unit on Medications and Pregnancy at University Hospital Center Sainte-Justine used information from the Quebec Pregnancy Registry to identify 5,124 women who had a spontaneous abortions between 1998 and 2003 -- before warnings about the risks of the drugs became more common -- and compared them with about 10 times that many carefully matched women who did not have abortions. A separate database provided information about prescriptions the women had filled.

The researchers reported in the Canadian Medical Assn. Journal that 5.5% of the women who had spontaneous abortions had taken antidepressants, compared with 2.7% of those who did not have a spontaneous abortion. Controlling for other factors, that amounted to a 68% increase in risk. The biggest effects were found with paroxetine (brand names Paxil and Seroxat) and venlafaxine (Effexor) or when combinations of drugs from different families were used. (...)

A Howe Road resident was arrested by Wellesley police.
needham.patch.com 8.6.2010
(...) The officer also observed that the woman's speech was slurred and her eyes were glassy. When the officer asked if she had been drinking, she said no, but she was on prescription drugs, Paxil and Amitrylane, and had taken more than the prescribed amount.

Pierce failed a field sobriety test, and was arrested and charged with operating under the influence of drugs, negligent operation and marked lanes violation. Her bail was set at $2,000, which she did not post, so she remained at the Wellesley Police Department and was transferred to Dedham District Court Monday morning. (...)

Glaxo, Paxil and the Catholic Sex Abuse Cover-Up: Drug Implicated in Priest's Suicide (Glaxo, Seroxat og det skjulte katolske sexmisbruk: Legemiddel implisert i prests selvmord)
industry.bnet.com 7.4.2010
GlaxoSmithKline (GSK), which was already the focus of controversy over whether it ignored the suicide risk of its antidepressant Paxil, has found itself linked to the Catholic Church’s cover-up of child abuse in the death of a priest who took the drug.

Download the Tucker v. GSK ruling here.

The case seems bound to become a further PR headache for GSK, which in 2008 was accused of obscuring the suicide risk of Paxil in studies for 15 years. (...)

The Time To File A Paxil Birth Defect Claim Is Running Out
1888pressrelease.com 18.3.2010
The time to file a claim for compensation for children born with congenital heart defects as a result of exposure to Paxil is running out.

New York, NY (1888PressRelease) March 18, 2010 - It appears that the time to seek compensation for birth defects allegedly caused by exposure to the antidepressant Paxil during pregnancy is running out. DrugSettlement.com reports that court records indicate many cases have been resolved and have been removed from the docket. Parents who took Paxil during pregnancy and gave birth to a child with a congenital heart defect should act quickly to determine whether they my file a claim on behalf of their child. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Depression or Sex?
diabeteshealth.com 16.3.2010
(...) Paxil is one of the SSRIs that is hardest on sexuality. One study showed that 14 percent of Paxil users spontaneously reported sexual problems. If specifically asked, however, 60 percent said they had problems. In a Spanish study, over 70 percent of women on paroxetine reported sexual dysfunctions. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Evelyn Pringle: Paxil Birth Defect Litigation
scoop.co.nz 18.2.2010
GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in 1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service. (...)

Popular antidepressant 'cancels out' effect of breast cancer drug (Populær antidepressiva "oppveier" effekt av legemiddel mot brystkreft)
telegraph.co.uk 9.2.2010
Breast cancer sufferers have been warned against taking a popular antidepressant as it interferes with cancer drug, researcher said.
Women who took both tamoxifen for their breast cancer and antidepressant paroxetine, also known as Seroxat, were more likely to die from their cancer than those on other depression drugs.

The researchers, writing in the British Medical Journal (BMJ), said their results had "major implications" and an accompanying editorial said the two should not be prescribed together. (...)

Selective serotonin reuptake inhibitors and breast cancer mortality in women receiving tamoxifen: a population based cohort study
BMJ 2010;340:c693 (8 February)
Objective To characterise whether some selective serotonin reuptake inhibitor (SSRI) antidepressants reduce tamoxifen’s effectiveness by inhibiting its bioactivation by cytochrome P450 2D6 (CYP2D6). (...)

Conclusion Paroxetine use during tamoxifen treatment is associated with an increased risk of death from breast cancer, supporting the hypothesis that paroxetine can reduce or abolish the benefit of tamoxifen in women with breast cancer. (...)

Firm halts antidepressant research
pharmacyeurope.net 5.2.2010
A major pharmaceutical firm is halting research into antidepressants in a bid to save £500m a year in costs by 2012.

GlaxoSmithKline announced the move as it unveiled an 18% rise in full-year pre-tax profits to £7.9bn. This was an increase of 16% to £28.4bn in the 12 months to December 31.

Antidepressant medicines have represented a major part of the company's sales, with more than £2bn generated from Wellbutrin and Seroxat or Paxil. The last drug was criticised by regulators and drew a series of litigations against the company. (...)

GSK to cut more jobs as it ends research into painkillers
business.timesonline.co.uk 4.2.2010
Hundreds of research and development jobs in the UK will go at GlaxoSmithKline, as Europe’s biggest pharmaceuticals company ends development of new depression and pain medicines. (...)

Typically, six large-scale clinical trials have to be carried out on a new antidepressant because of the difficulty in measuring, clinically, whether they have succeeded.

A degree of controversy has attached itself to Paxil, GSK’s biggest-selling antidepressant, which is also known as Seroxat, after it was linked to an increased risk of suicide in some cases. The company has agreed to pay about $100 million (£63 million) to settle a number of lawsuits relating to the drug. (...)

Antidepressants may delay breast milk production
reuters.com 1.2.2010
NEW YORK (Reuters Health) - Widely used antidepressants known as selective serotonin reuptake inhibitors (SSRIs) may delay a woman's breast milk production soon after giving birth, a new study hints.

In a survey of 431 women who gave birth at one U.S. medical center, researchers found that seven of the eight women on SSRIs did not have their breast milk come in within the typical 72 hours of giving birth. On average, their full breast milk production was delayed by about a day compared with other mothers.

In a separate part of the study, the investigators also found that SSRI medication affected the functioning of human cell samples from the breast tissue lining, and appeared to alter breast milk production in lab mice.

After giving birth, women produce a precursor to breast milk called colostrum until their full breast milk comes in; if that shift does not happen within 72 hours, researchers consider it "delayed secretory activation." (...)

Antidepressants Linked to Breastfeeding Problems in New Mothers
insciences.org 1.2.2010
(SACRAMENTO, Calif.) — New mothers who take common antidepressant drugs may not just be suppressing depression. They also may be suppressing their milk production in the early postpartum period, according to a new study.

Published in the February issue of the Journal of Clinical Endocrinology & Metabolism, the study found that new mothers taking certain antidepressants may experience a condition called “delayed secretory activation," or a delay in the initiation of complete milk secretion. (...)

Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data.
Psychol Med. 2010 Jan 5:1-11. [Epub ahead of print]
(...) CONCLUSIONS: Women using antidepressants during pregnancy and their newborns have increased pathology. It is not clear how much of this is due to drug use or underlying pathology. Use of TCAs was found to carry a higher risk than other antidepressants and paroxetine seems to be associated with a specific teratogenic property. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: teratogen; som skaper misfoster, som er årsak til lyte hos foster; særleg brukt om visse kjemiske stoff eller medikament. EN teratogenic. ET [gr teras misfoster + gennan skapa]. Kilde: Norsk medisinsk ordbok.)

Study Undermines Case For Antidepressants (Studie undergraver bevis for antidepressiva)
forbes.com 5.1.2010
(...) Såkalte selektive serotoninreopptakshemmere (SSRIer) slik som Seroxat, Prozac og Zoloft, er utstrakt brukt på bakgrunn av teorien om at deprimerte mennesker lider av mangel på hjernekjemikaliet serotonin. Men få harde data støtter det populære konseptet, ifølge Kirsch. "Hele idéen med serotoninmangel er en myte." (...) (So-called selective serotonin reuptake inhibitors such as Paxil, Prozac and Zoloft, gained widespread use on the theory that depressed people suffer from a deficit of the brain chemical serotonin. But little hard data supports the popular concept, Kirsch says. "This whole idea of serotonin deficiency is a myth.")

Det er ikke eksakt kjent hvor mange pasienter med mild depresjon som tar antidepressiva. Men en undersøkelse sitert av forskerne fant at 71 % av alle pasienter som søker behandling for depresjon faller i den mildere kategori, hvor det er sannsynlig at placebo virker like bra. (...) (It is unknown exactly how many patients taking antidepressants have milder cases of depression. But one survey cited by the researchers found that 71% of all patients seeking treatment for depression fall in the milder category, where placebos are likely to do as well.)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: Svindelen som aldri tar slutt (forskning.no 17.4.2004).)

(Anm: Antidepressant Drug Effects and Depression Severity A Patient-Level Meta-analysis. JAMA. 2010;303(1):47-53 (January 6).)

Charles Nemeroff And The House That Glaxo Built? (Charles Nemeroff og huset som Glaxo bygget?)
pharmalot.com 4.1.2010
Charles Nemeroff, the controversial psychiatry professor who became a subject of a US Senate Finance Committee inquiry into academic research and pharma industry influence, is joining the University of Miami’s Miller School of Medicine. Of course, this means leaving his previous job at Emory University in Atlanta and so he’s just purchased a $1.9 million house in the Coconut Grove section of Miami. The 5,204-square-foot home has six bedrooms and seven bathrooms, according to BlockShopper. (...)

Grassley’s probe prompted Emory to suspend Nemeroff’s work on an NIH grant and asked him to step down as chair of psychiatry while it studied his conduct (look here). And the Department of Health and Human Services Office of Inspector General began an inquiry into Emory’s handling of the matter (see this). Meanwhile, Pascal Goldschmidt, the Miller school dean, recently told The Miami Herald that he read reports from Emory about Nemeroff’s activities and found nothing to indicate that payments the psychiatrist received had in any way influenced his research results.

In any event, the new home appears big enough to house plenty of consulting materials. (...)

Psychiatrist spends $1.91M on Miami 6BD
southflorida.blockshopper.com 30.12.2009
Dr. Charles B. Nemeroff and Gayle Nemeroff bought a six-bedroom, seven-bath home at 1780 Espanola Dr. in Miami from David and Carolyn Shulevitz for $1.91 million on Dec. 4. (...)

Dr. Nemeroff is a geriatric psychiatrist and an associate at the Emory University Winship Cancer Center. He joined the faculty of Emory University in 1991 and he is also affiliated with Wesley Woods Geriatric Hospital in Atlanta. (...)

GlaxoSmithKline told to pay family $2.5m after jury finds paroxetine caused son’s heart defects (GlaxoSmithKline pålagt å betale familie 2,5 millioner dollar etter at jury finner at Seroxat (paroxetine) forårsaket sønnens hjertedefekter)
BMJ 2009;339:b4266 (15 October)
A Philadelphia jury has found that the antidepressant paroxetine (marketed as Paxil in the United States and Seroxat in the United Kingdom) caused heart defects in a child, Lyam Kilker, whose mother Michelle David took the drug while pregnant. The jury has awarded the family $2.5m (£1.5m; 1.7m) in compensation.

The trial was the first of about 600 US lawsuits that claim that paroxetine caused birth defects in infants born to mothers who took the drug while pregnant (BMJ 2009;339:b3967, doi:10.1136/bmj.b3967). (...)

Seroxat to blame for baby's heart defects, American jury rules
guardian.co.uk 14.10.2009
(...) Thousands of women worldwide have taken antidepressants such as Seroxat in pregnancy, assured by manufacturers and doctors that they are safe. The case is one of a number in the US and the first to end in a verdict against the company. (...)

A number of studies have suggested that rates of congenital heart defects are higher among women taking Paxil and other drugs of the SSRI (selective serotonin reuptake inhibitor) class. David Healy, professor of psychiatry in Bangor, Wales, who gave evidence in the Kilker case, said that at 4%, the rate of birth defects was double the normal rate, while the rate of major defects was 2% compared with 1%. The general rate of miscarriages is 8%, but 16% of women on Seroxat miscarry. (...)

Glaxo Ordered to Pay $2.5 Million for Paxil Defects (Update3)
Bloomberg.com 13.10.2009
Oct. 13 (Bloomberg) -- GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial. (...)

First Paxil Birth Defect Lawsuit is Set to Begin (Første søksmål om Seroxat-induserte fødselsdefekter starter)
chicagobirthinjurylawyerblog.com 15.9.2009
The first Paxil lawsuit against GlaxoSmithKline over alleged birth defects caused by the antidepressant is scheduled for trial to begin today in Philadelphia. This is one of approximately 600 similar claims involving heart defects and other injuries suffered by babies born to woman who used Paxil. The birth injury lawsuit claims that the use of Paxil resulted in life-threatening heart defects in her three-year-old son. Paxil is a selective serotonin reuptake inhibitor prescribed to treat depression. It is one of the most common drugs prescribed in the United States. (...)

Trial opens here in Paxil lawsuit
philly.com 15.9.2009
GlaxoSmithKline P.L.C. for years ignored evidence that its antidepressant Paxil may have caused birth defects, a lawyer told a Philadelphia jury today on behalf of a woman who says that taking the drug during her pregnancy caused her three year-old son's heart problems. (...)

The trial is the first of more than 600 cases alleging that Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. Approved for U.S. use in 1992, the drug generated about $942 million in sales last year, 2.1 percent of Glaxo's total sales. (...)

In the late 1980s, at about the same time as the rat study, an internal Glaxo scientist warned that "there remains the possibility that this compound could be teratogenic at higher dose levels." A teratogenic agent is one that can cause birth defects. Tracey said Glaxo had ignored links between Paxil and birth defects for 20 years. (...)

Glaxo E-Mails Over Paxil Study Must Be Turned Over (Update1)
Bloomberg.com 15.9.2009
Sept. 15 (Bloomberg) -- GlaxoSmithKline Plc’s e-mail with researchers studying birth defects allegedly caused by the drugmaker’s antidepressant Paxil must be turned over to a family suing over the drug. (...)

IMB advises against 'Seroxat' in pregnancy (IMB advarer mot Seroxat i svangerskapet)
irishtimes.com 18.8.2009
THE IRISH Medicines Board (IMB) has advised women who want to become pregnant and are taking the antidepressant Seroxat to discuss the risks and benefits of continued treatment beforehand with their doctor.

It has also advised that pregnant women who are taking the antidepressant should not stop their treatment without seeking advice from their doctors.
Some studies have found an increased risk of birth defects, particularly heart defects, associated with the use of Seroxat during the first three months of pregnancy. These findings are not new, but last week Irish psychiatrist Prof David Healy, who is based in Wales, said he believed many GPs still prescribed Seroxat to women without adequately informing them of the risks. (...)

A number of legal actions will soon begin in the US over the antidepressant. Lawyers representing women suing GlaxoSmithKline claim the manufacturer knew, or should have known, about the birth defects more than 10 years ago because of research findings. (...)

GSK steps up commitment to research transparency
pharmatimes.com 25.3.2009
GlaxoSmithKline (GSK) has sought to draw a line under the reputation for data distortion that has plagued the company since its tangles with regulators and the media over the antidepressant Seroxat/Paxil (paroxetine) by announcing a clutch of initiatives to enhance the transparency of its clinical research.

The measures are disclosed in GSK’s latest annual Corporate Responsibility Report, which recognises the company’s “unique and privileged” position. “Continually strengthening our contract with society is vitally important, and this is why we are fully committed to operating to the highest ethical standards,” commented chief executive officer (CEO) Andrew Witty. (...)

Paxil Birth Defects – The Never-Ending Vigil
lawyersandsettlements.com 22.3.2009
Springhill, FL : Kristine's son was born without incident – a healthy baby boy. He is now 4 years old and was recently diagnosed with a condition that could kill him if his parent's aren't vigilant. It turns out he was born with this condition, and Kristine wonders if the Paxil she took while pregnant could have contributed – could it be a Paxil birth defect? (...)

Paxil isn't the only drug that has been linked with birth defects. The SSRIs Prozac by Eli Lilly, Zoloft by Pfizer, and Celexa and Lexapro sold by Forest Laboratories, along with various generic versions of the drugs are also controversial. And the closely-related class of SNRI antidepressants, which include Wyeth's Effexor and Lilly's Cymbalta, also carry birth defects warnings.

Just what are the birth defects? The published studies so far, and they are few, highlight the risk for persistent pulmonary hypertension (PPHN), and this is what the package warnings refer to.

However, in 2007, a study published in the New England Journal of Medicine showed that the use of antidepressants in the first 3 months of pregnancy more than doubles the risk of and craniosynostosis (premature closure of the connections between the bones of the skull before brain growth is complete), omphalocele (the child's abdomen does not close properly allowing intestines and other organs to protrude outside the body), and anencephaly (birth without forebrain). (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

U.S. to Probe Emory, Nemeroff
emorywheel.com 7.3.2009
The federal government may investigate former psychiatry chairman Charles B. Nemeroff’s consulting activities to gauge whether he fulfilled his required time commitments as chief investigator of multiple research grants from the National Institutes of Health (NIH).

Sen. Charles Grassley (R-Iowa), the ranking Republican on the Senate Finance Committee, sent a letter to the inspector general of the U.S. Department of Health and Human Services (HHS), prodding him to investigate the conflict-of-commitment matter. The letter, made public on Feb. 24, also questioned whether Emory reported conflict-of-interest issues to the NIH in good faith. (...)

Based on information that was made public last fall, Grassley states in his letter that Nemeroff was a guest speaker who trained PsychNet doctors in the advocacy of GSK’s Paxil product. PsychNet is a program created by GSK to train doctors in promoting Paxil. According to public documents, Nemeroff served in this capacity in 2000.

University President James W. Wagner said the “real thrust of this [new investigation] was to question the conflict of commitment, which is something, very frankly, we need to look into.”

He said the University will look at whether Nemeroff was overcommitted in time to the University, the NIH and GSK. (...)

Drug Approval Is No Legal Shield, Justices Rule (Legemiddelgodkjenning er ikke rettslig skjold mot søksmål, ifølge domstolkjennelse)
nytimes.com 4.3.2009
WASHINGTON — In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators. (...)

Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity
J. Med. Ethics 2009;35;107-112 (14 February)
ABSTRACT
This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not
to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines. (...)

Paxil and How it affects YOU (Seroxat og hvordan den påvirker DEG)
galvestonbay.injuryboard.com 19.2.2009
Paxil is a prescription drug approved to treat depression, general anxiety disorder, social anxiety, obsessive-compulsive disorder, and post traumatic stress disorder. Although the FDA approved Paxil in 1993, there are many side effects that users should be aware of. Studies show that nearly twenty percent of all clinical trial patients in Paxil studies have had to discontinue treatment because of significant Paxil side effects.

Paxil has had many physical and psychological problems with people taking the antidepressant. If you are a patient taking Paxil, you should discuss your full medical history with your physician prior to starting treatment. Patients with a history of kidney problems, seizures, glaucoma, or problems with similar medications might be at a greater risk of suffering serious Paxil side effects. Some side effects of Paxil include: allergic reaction, irregular heart beat, abnormally high or low blood pressure, fever or chills, gastrointestinal problems, and other complications. Serious physical Paxil side effects can also occur when a patient overdoses on this drug. Serious side effects of Paxil can occur if the patient discontinues using the drug or modifying their treatment. (...)

Paxil Can Effect Our Youth in A Negative Way (Seroxat kan påvirke unge på en negativ måte)
galvestonbay.injuryboard.com 19.2.2009
Has your teen been prescribed Paxil? Did you know that it has now been linked with suicide and violence in children and teenagers? The FDA issued a caution on Paxil in May of 2006 due to a study of 15,000 patients where 11 revealed suicidal attempts, all of which were taking Paxil for depression.

Of the 11 people, 8 were aged 18-30 and now an estimated 17 million people worldwide have been treated with Paxil. The FDA eventually issued a warning for Paxil in September of 2004 stating that the drug can cause suicidal and violent behavior in children and teenagers. The FDA now continues to investigate the suicidal risk associated with Paxil and other antidepressants. (...)

Hormone Level During Pregnancy May Identify Women At Risk For Postpartum Depression
medpagetoday.com 3.2.2009
Women who have higher levels of a hormone produced by the placenta midway through their pregnancy appear more likely to develop postpartum depression, according to a report in the February issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

Postpartum depression (PPD) is more serious than "baby blues" and begins within four to six weeks of giving birth, according to background information in the article. Risk factors include a history of depression, stressful life events, a lack of social support, low self-esteem and depression, anxiety or stress during pregnancy. However, these risk factors explain only a portion of the differences between women who develop PPD and those who do not. (...)

Risk of Postpartum Depressive Symptoms With Elevated Corticotropin-Releasing Hormone in Human Pregnancy
Arch Gen Psychiatry. 2009;66(2):162-169. (February)
(...) Conclusions At a critical period in midpregnancy, pCRH is a sensitive and specific early diagnostic test for PPD symptoms. If replicated, these results have implications for the identification and treatment of pregnant women at risk for PPD. (...)

Emory will punish psychiatrist Nemeroff (Emory vil straffe psykiater Nemeroff)
ajc.com 23.12.2008
Chairmanship taken away, outside income to be vetted

Emory University on Monday permanently stripped Dr. Charles B. Nemeroff of his department chairmanship and placed severe restrictions on the internationally known psychiatrist’s extracurricular activities.

Emory’s announcement followed an internal investigation into $800,000 in payments made to Nemeroff by the global pharmaceutical company GlaxoSmithKline between January 2000 and January 2006. Nemeroff received the payments for more than 250 speeches he made to other medical professionals. (...)

How Common or Significant Is Serotonin Syndrome? (Hvor vanlig eller viktig er serotonin syndrom?)
medscape.com 10.11.2008
We are seeing more patients who are taking multiple antidepressants of different classes. All drug interaction programs cite drug-drug interactions leading to the potentially severe toxicity known as serotonin syndrome. Just how common and clinically significant is serotonin syndrome?

The Toxic Exposure Surveillance System reviewed cases from office-based practices, inpatient settings, and emergency departments and found that during 2004, selective serotonin reuptake inhibitors (SSRIs) caused significant toxic effects in 8187 persons, leading to 103 deaths.[1] The true incidence of serotonin syndrome and associated morbidity are likely to be much greater. This syndrome may be underdiagnosed given the fact that SSRIs are not the only contributing class of agents. Moreover, it has been suggested that more than 85% of physicians are unaware that the syndrome even exists.[2] (...)

Antidepressant treatment may reduce male fertility
reuters.com 10.11.2008
NEW YORK (Reuters Health) - Treatment with paroxetine (Paxil), which belongs to the selective serotonin reuptake inhibitor (SSRI) class of antidepressant drugs, increases DNA fragmentation in sperm, according to research presented today at the 64th annual meeting of the American Society for Reproductive Medicine in San Francisco. (...)

Emory University psychiatrist intentionally hides $960,000 received for speeches and “research” in support of GlaxoSmithKline’s anti-depressant drug, Paxil (Professor ved Emory University skjuler bevisst 960 000 dollar, som betaling for foredrag og "forskning", til støtte for GlaxoSmithKlines antidepressiva Seroxat)
westtnliving.wordpress.com 5.10.2008
The following is an excerpt from an article published in the Wall Street Journal on Saturday: (read full article, click here.):

“A prominent Emory University psychiatrist failed to tell the school about $500,000 he received from drug maker GlaxoSmithKline PLC while heading a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.

The payments to Charles Nemeroff, chairman of the Atlanta university’s psychiatry department, compensated him for making presentations to doctors about Glaxo drugs, including its big-selling antidepressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday…. (...)

Spitz: Pill leaves a bitter aftertaste
milforddailynews.com 25.9.2008
This pill will change your life.

No, really. It will. Just ask Cally Egan. She knows.

"Sun not shining bright enough for you? Here, take this." (...)

"If I'd known what Paxil was going to do to me, I would have suffered through my anxiety for every day for the rest of my life if I had to." (...)

Egan was given Paxil, a selective serotonin reuptake inhibitor (SSRI) that was the first antidepressant formally approved in the United States for treatment of panic attacks. Prescribed in varying doses, pills and liquid, it was the fifth most commonly prescribed antidepressant in the country two years ago. (...)

"They don't call it withdrawal, because (drug manufacturers like Paxil's GlaxoSmithKline) say it's not addictive. They call it discontinuation syndrome. Which I think is just a fancy name for withdrawal.

"When I first started weaning, I was going way too fast. ... I got these brain zaps. Zzzz-tt. You can actually hear it and feel it. ... I was shaking for hours. ... Your whole gastrointestinal system goes insane." (...)

As Egan sees it, and publications including the Journal of the American Medical Association acknowledge, drug companies exert too much influence over doctors.

"They get all this cool stuff from the drug reps. ... Drug dealers. That's exactly what they are."

Still, "the drug reps are only getting the information that the drug companies are willing to give them." And doctors don't always have the time to thoroughly investigate each drug, and who authored the study supporting the medication's uses.

That's why Egan has this advice for those at the crossroad she was nine years ago: "If their doctor wants to put them on medication, go online and research it, the pros and the cons. You've got to get as much information as you can.
"And always read the inserts that come with the medication." (...)

DrugSettlement.com
drugsettlement.com (13.9.2008)
ALERT:
DrugSettlement.com, LLC, reports that one of its member firms, Nix & McIntyre, LLP,, has been ordered by Judge Claire V. Eagan of the United States District Court for the Northern District of Oklahoma, to commence the first federal Paxil Birth Defect trial on January 20, 2009. The case has been profiled in a television news story by News9 in Oklahoma City, Oklahoma. (...)

Side Effects for Paxil babies include, but are not limited to the following:

• * Heart Birth Defects (Atrial or Ventricular Septal Defects, Murmurs, etc)
• * Lung Birth Defects (Persistent Pulmonary Hypertension)
• * Craniosynostosis (resulting in an abnormally shaped head)
• * Abdominal Birth Defects (Omphalocele)
• * Cranial Birth Defects (Craniosynostosis) (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Glaxo Loses Preemption Ruling In Paxil Suicide
pharmalot.com 29.8.2008
On September 14, 2002, 16-year-old Jake Garrison shot himself to death, eight months after first being prescribed the Paxil antidepressant. And so a lawsuit was filed against Glaxo, claiming the drugmaker knew there were risks associated with off-label use pediatric use of Paxil and, therefore, had a duty to warn of those risks. (...)

Senator Charles Grassley Investigation of GSK -
Based on Paxil Suicide Documents Obtained by Baum Hedlund
baumhedlundlaw.com (19.7.2008)
Senator Charles Grassley (R-Iowa), a ranking member of the Senate Finance Committee, launched an investigation of GlaxoSmithKline (GSK) regarding its controversial antidepressant Paxil based on GSK documents collected by Baum Hedlund during Paxil suicide litigation.
See: http://finance.senate.gov/press/Gpress/2008/prg061208.pdf (...)

Drug story adds little to the headlines
philly.com 22.6.2008
Account of Glaxo's role in promoting Paxil for children could have answered important questions. (...)

The Paxil mess is one everyone interested in consumer fraud or safety in medicine should know about, and it has been widely reported. The present book is an attempt to go beyond the news articles to tell a fuller, more human story. In this, unfortunately, it falls short. (...)

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial
By Alison Bass. 260 pp. Chapel Hill, NC, Algonquin Books of Chapel Hill, 2008. $24.95. ISBN 978-1-56512-553-7.
NEJM 2008; 358:2852 (June 26)
In July 2003, Rose Firestein, a tenacious lawyer working with the New York State attorney general's office on a consumer fraud lawsuit against GlaxoSmithKline, noticed something curious on the Web site of the Food and Drug Administration (FDA) — a press release stating that three clinical trials of the company's antidepressant Paxil (paroxetine) in children with depression showed that the drug was no more effective than a placebo. Firestein was shocked, given that Paxil was the second most widely prescribed antidepressant for children.

Firestein kept digging and quickly discovered that GlaxoSmithKline had actually conducted nine clinical trials with Paxil but had published just one of them. What the drug maker was hiding from the public was the bad news about Paxil: it did no better than a placebo in at least two of the unpublished studies, and there was disturbing evidence that patients who took Paxil were nearly three times as likely to experience suicidal feelings, thoughts, and behavior as those who took a placebo. (...)

Tyverb approved in EU but US senator attacks GSK over Paxil
pharmatimes.com 13.6.2008
Regulators in Europe have granted marketing authorisation, albeit conditionally, to GlaxoSmithKline's breast cancer compound Tyverb. (...)

Less welcome for GSK was the news that US Senator Charles, an outspoken critic of the pharmaceutical industry and its regulators, has asked the Food and Drug Administration to investigate whether the firm withheld data about a risk of suicide linked to the antidepressant blockbuster Paxil/Seroxat (paroxetine). (...)

The senator asked GSK about the Glenmullen report last February and the firm believes it responded fully to his questions. When the aforementioned report came out, the company was dismissive of his findings and said that Dr Glenmullen “carefully selected excerpts from GSK documents and made his own interpretations without looking at the totality of the data”. (...)

End of an era for Glaxo's Garnier
bbc.co.uk 21.5.2008
Jean-Pierre Garnier revamped drug development at GSK

Jean-Pierre Garnier bowed out as chief executive of the global drugs giant GlaxoSmithKline(GSK) on Wednesday. (...)

Fat cat revolt
Today's shareholder gathering was a friendly affair compared with five years ago.

Then, the GSK boss faced the biggest rebellion a major listed company had ever seen.

Investors voted against his £18m pay deal, seen as excessive in light of the company's poor performance, a turning point in the fight against fat cat pay.
The company's reputation has also been dented by safety scares.

Sales of its diabetes treatment, Avandia, were hit last yeat after research linked it to an increase in heart attacks.

Last year, it was also accused of holding evidence about potential side-effects of its anti-depressant drug Seroxat.

Mr Garnier also tried to stop the South African government from sourcing cheaper, generic HIV drugs from countries like India. He later changed tack and offered not-for-profit HIV drugs to the nation. (...)

JP Garnier leaves bitter-sweet pill for Glaxo to swallow
guardian.co.uk 20.5.2008
Frenchman made bold, sweeping changes - and was copied by many (...)

Big new products have been developed but a number have been dogged by safety scares. GSK's drug for diabetes, Avandia, has been linked in a study to an increase in heart attacks, causing sales to plummet. GSK's reputation was also damaged after an investigation found the company had withheld evidence that a controversial drug, Seroxat, increased the likelihood of suicide among teenagers. (...)

Tough questions
When Jean-Pierre Garnier was interviewed by James Naughtie on Radio 4's Today programme yesterday he faced questioning over whether GSK was prepared to make public all information about the potentially dangers of Seroxat. As the interview progressed Garnier became increasingly annoyed when challenged on the issue. "Either you want me to answer the question or you don't," said Garnier after Naughtie interrupted one of his answers. When the interviewer asked Garnier about a request from the government regulator MHRA for GSK to put all information about the possible dangerous side effects of Seroxat into the public domain, Garnier said GSK had said it will handle all information requests on Seroxat. When asked whether he will leave a company that will "be honest" about the safety of its drugs Garnier drew the interview to a close. GSK has denied it has improperly withheld Seroxat data and said it has never been marketed to under-18s. Regulators in Britain and the US have not passed the drug for under-18s. (...)

Tampa woman charged with child neglect after passing out, leaving child to fend for herself
abcactionnews.com 14.4.2008
TAMPA -- A woman is in custody for child neglect this morning after mixing prescription medication with alcohol and leaving her 2-year-old child to fend for herself.

Neighbors saw Tiffany Garland's daughter playing on the balcony and eating cigarette butts for at least four hours.

According to reports, Garland took the antidepressant Paxil and drank an unspecified amount of tequila.

The child was seen on the balcony a short time after and police were called.

Garland, 21, lists her place of employment as Mons Venus in Tampa, where she works as an entertainer.

The child is now in the father's custody. (...)

GSK Investigation Concludes (GSK-granskning konkluderer)
medicalnewstoday.com 11.3.2008
The MHRA has concluded its four year investigation into Glaxosmithkline and its antidepressant drug Seroxat. The investigation focused on whether GSK had failed to inform the MHRA of information it had on the safety of Seroxat in under 18's in a timely manner. The investigation was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation. It was the largest investigation of its kind in the UK, and included the scrutiny of over 1 million pages of evidence. (...)

GSK provided the MHRA with data from clinical trials in May 2003, confirming that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo; and that Seroxat was ineffective in treating depressive illness in under 18's. Acting upon this information the MHRA immediately reviewed the data and published advice to all doctors that Seroxat should not be used in under 18's. The investigation arose from concern that GSK had held the information for some time before this and failed to disclose it. (...)

Suicide Warning Suits Pre-Empted; Makers of Paxil, Zoloft Win
law.com 10.4.2008
In a significant victory for drug manufacturers, the 3rd U.S. Circuit Court of Appeals has ruled that the makers of Paxil and Zoloft cannot be sued for failing to warn of a risk of suicide because the Food & Drug Administration has explicitly refused to order such warnings.

Voting 2-1 in a pair of cases where the lower courts issued conflicting rulings, the 3rd Circuit found that such lawsuits must be pre-empted because they directly conflict with action already taken by the FDA. (...)

Glaxo Fights Against Public Paxil Trials (Glaxo kjemper mot offentlige Seroxat-rettssaker)
by Evelyn Pringle Page 1 of 7 page(s)
opednews.com 7.4.2008
Washington - Government attorneys appointed by the Bush Administration have been supporting GlaxoSmithKline in a number of courts across the country in an effort to convince the courts that lawsuits filed by victims of Paxil-induced injuries should be dismissed before ever making it to a jury.

In fact, the Administration has spent a massive amount of tax dollars filing amicus briefs on behalf of just about every drug maker involved in litigation in an attempt to get the lawsuits filed by private citizens thrown out of court.

The government claims that, once a drug and the warnings on its label are approved by the FDA, claims alleging injuries caused by a company's failure to warn about a risk not listed on the label are preempted. (...)

Man crazed by drink and drugs cocktail
bordercountiesadvertizer.co.uk 18.3.2008
A MAN who took anti-depressant tablets and then drank alcohol later proclaimed himself the Son of God in an Oswestry kebab shop. (...)

When he was put in a police car Grover had to be stopped from strangling himself with the rear seat belt. (...)

Mr Paul Nicholas said that the Seroxat tablets kept Grover's depression under control but should not be mixed with alcohol.

He had already apologised to the kebab shop owners and did so again in court. He had been back to the shop as a customer on a number of occasions without any problems. (...)

Man claims devil inspired attack
indystar.com 18.3.2008
SOUTH BEND. Ind. -- A man charged with beating another man in the head with a metal bar told officers the devil made him do it, police said.

According to a police report, Leo Wantuch III, 37, of Mishawaka told authorities the devil began controlling him after he started taking the antidepressant drug Paxil about six years ago. (...)

Wantuch reportedly told police he wanted to draw attention to the effects of Paxil. A telephone message seeking comment was left Monday with GlaxoSmithKline, the maker of Paxil. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Glaxo Escapes Prosecution For Hiding Deadly Side Effects (Glaxo slipper søksmål for å hemmeligholde dødelige sideeffekter)
torontodailynews.com 11.3.2008
Britain's top drug regulator on Thursday chided GlaxoSmithKline for not quickly releasing data on increased suicidal risk in patients under 18 who used its Seroxat antidepressant drug, but declined to press criminal charges. (...)

Seroxat lessons
ft.com 9.3.2008
Efforts by British medicine regulators to prosecute GlaxoSmithKline for allegedly delaying and playing down warnings about suicidal feelings in children taking Seroxat, its antidepressant, have collapsed after more than four years. Everyone involved should draw the lessons far more swiftly.

The regulatory framework has improved, partly in response to the GSK case. Drug companies are now required to register and report to regulators more extensively on side-effects identified during clinical trials conducted within the European Union. They also voluntarily and publicly disclose details of trials. (...)

GSK at centre of a moral storm over disclosure of data
pharmatimes.com 7.3.2008
GlaxoSmithKline may have escaped the threat of prosecution after being accused of delaying the submission of safety data concerning the antidepressant Seroxat but the firm’s reputation, and indeed that of the whole industry, is under scrutiny again.

As we reported yesterday, the Medicines and Healthcare products Regulatory Agency, after a four-year probe, said that GSK had delayed providing it with clinical data showing that patients under the age of 18 taking Seroxat (paroxetine) were at a higher risk of suicidal behaviour than those given a placebo. The company vehemently disputes this claim, saying that it complied with all the regulatory norms. (...)

In a letter to GSK’s chief executive Jean-Pierre Garnier, Prof Woods started by saying that “there is obviously a need to tighten the law to make it absolutely clear that pharmaceutical companies have a legal responsibility to inform the regulator of any information that changes the benefit:risk profile of their products, regardless of whether the information relates to a licensed indication”. (...)

GlaxoSmithKline in the clear over Seroxat data delay
pharmatimes.com 6.3.2008
GlaxoSmithKline will be breathing a sigh of relief this morning after UK regulators ruled that the company should not be prosecuted for a breach of drug safety regulation regarding its antidepressant Seroxat. (...)

Weak legislation
While the Agency’s investigation has concluded that the information should indeed have been reported earlier, it believes that, because legislation at the time was not comprehensive enough as to require companies to submit safety data when the drug was being used or tested outside its licensed indications, there is no realistic prospect of a conviction and so the case should not proceed to criminal prosecution.

“I remain concerned that GSK could and should have reported this information earlier than they did [but] this investigation has revealed important weaknesses in the drug safety legislation in force at the time”, commented Professor Kent Woods, the MHRA’s chief executive. And he went on to say that, while subsequent legislation has partially addressed the problem, “we will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies’ obligations to report safety issues.” (...)

Pensioner Denies Assaulting GP In Row Over Anti-Depressant Drug
derryjournal.com 22.2.2008
A sixty-nine years old retired civil servant has gone on trial in Derry
charged with punching his doctor in the face in the city's Clarendon Medical
Centre.

John Francis Bradley from Academy Road, denies a charge of common assault
against Dr. Ian Palin. He's alleged to have committed the offence in the
doctor's surgery on May 15, 2006, when they had a disagreement about the
defendant's continued use of the anti-depressant drug Seroxat. (...)

Paxil Risks at Center of Grassley Probe (Farer ved Seroxat i fokus for Grassley-granskning)
forbes.com 6.2.2008
WASHINGTON - A leading Republican senator is investigating whether GlaxoSmithKline knew about the suicide risks of its antidepressant Paxil more than 15 years before it warned the public. (...)

Britney umyndiggjort
nrk.no 4.2.2008
En domstol i Los Angeles har midlertidig erklært popstjernen Britney Spears umyndig og fratatt henne råderetten over sine midler. (...)

King & Spalding Earns Victory in Products Liability Case for GlaxoSmithKline
infobolsa.es 1.2.2008
GlaxoSmithKline 01/02/2008 17:25:00 Business Wire King & Spalding, a leading international law firm, has earned a significant victory for client GlaxoSmithKline ("GSK") in a products liability case.

On January 30, a federal district judge granted summary judgment in O Neal v.
SmithKline Beecham d/b/a GlaxoSmithKline and dismissed, with prejudice, all claims made by the plaintiff in a case involving the 1997 suicide of a 13 year-old

This is the fourth major win in a series of victories over the past several months regarding suits filed against the drug manufacturer of the antidepressant drug Paxil. (...)

Topless Britney Spears Told Cops: 'I'm F****** Hot!'
entertainmentwise.com 14.1.2008
Police sources lift the lid on last week's hostage drama... (...)

The singer's assistant, who was present during the stand-off, told officers that her boss had been "popping" "vitamins" all day.

Officers found a bottle of Prozac in her bedroom, say TMZ.com. (...)

Nail gun murder: life in prison without parole
theunion.com 4.1.2008
(...) Reynen looked Williams in the eye and told him he has no pity for him. He said he does not believe the excuse Williams gave during trial for the killing: withdrawal from the anti-depressant Paxil made him kill Hetty. (...)

PM’s drugs vow (Statsministers legemiddelløfte)
huntspost.co.uk 5.12.2007
DRUGS giant GlaxoSmithKline will be prosecuted if an investigation finds the company withheld information that the drug Seroxat has a higher suicide risk for under 18s.

This promise was made by Gordon Brown on Thursday at a Downing Street meeting with a campaigner from Huntingdon.

Janice Simmons, founder of the Seroxat User Group, wants to see the drug banned and patients trying to come off it given more help.

The PM stressed the investigation by the Department of Health, which has been going on for four years, was a serious inquiry.

The drugs company denies the allegation, saying Seroxat was never licensed for children. (...)

Although odd, Ricky Williams isn't without his charms
profootballweekly.com 23.11.2007
The Dolphins are 0-10 against the NFL, and Ricky Williams is 0-4 against the league’s drug policies. As for which one will achieve something positive first, the inclination here is to decide, “Neither.” (...)

Accepting Williams means accepting his lifestyle. He is a vegetarian. He has been diagnosed with social anxiety disorder, which he has struggled to deal with. To alleviate his symptoms, he smoked marijuana and consequently was penalized. Williams briefly was a spokesman for the drug Paxil as treatment. He later quit Paxil, explaining that the drug did not agree with his diet. Marijuana, he contended, was a better form of treatment since it produced fewer side effects. (...)

Talking Back to Prozac
nybooks.com 6.12.2007 (VOLUME 54, NUMBER 19 • DECEMBER 6, 2007)
During the summer of 2002, The Oprah Winfrey Show was graced by a visit from Ricky Williams, the Heisman Trophy holder and running back extraordinaire of the Miami Dolphins. Williams was there to confess that he suffered from painful and chronic shyness. Oprah and her audience were, of course, sympathetic. If Williams, who had been anything but shy on the football field, was in private a wilting violet, how many anonymous citizens would say the same if they could only overcome their inhibition long enough to do so? (...)

Little of what we see on television, however, is quite what it seems. Williams had an incentive—the usual one in our republic, money—for overmastering his bashfulness on that occasion. The pharmaceutical corporation GlaxoSmithKline (GSK), through its public relations firm, Cohn & Wolfe, was paying him a still undisclosed sum, not to tout its antidepressant Paxil but simply to declare, to both Oprah and the press, "I've always been a shy person." (...)

CLEAN COMEBACK
sfgate.com 18.11.2007
Williams hopes to shed hazy image in another return to Dolphins

-- If you need to make good with the boss, take some tips from Ricky Williams. The 1998 Heisman Trophy-winning running back knows what it takes to get back in an employer's good graces: (...)

When he publicly confessed that he found marijuana to be "10 times more helpful than Paxil," the drugmaker GlaxoSmithKline promptly pulled his picture and endorsement from its Web site. Bummer! If you're Williams, you have to understand you work for an employer, the NFL, that expressly forbids the use of weed, either for recreational or medicinal use. This might seem unfair, but that's the way it is. (...)

Man takes on pharmaceutical giant
newburytoday.co.uk 17.11.2007
A THATCHAM man is at the centre of a legal test case against pharmaceutical giants Glaxosmithkline UK.

In a writ issued at London's High Court, Philip Roberts alleges that he suffered undisclosed personal injuries after taking the drug Seroxat, also known as parexetine, between January 1998 and April 2005.

Mr Roberts, of Quarrington Close, Thatcham, is claiming damages of up to £50,000.

He is the latest in a group of several hundred people who want to sue the makers of the anti-depressant drug manufacturer, claiming that their lives have been blighted by addiction to it.

The drug was banned for under-18s in 2003 after a government watchdog found it trebled the risk of suicidal thoughts in depressed children.
In January 2007, BBC's Panorama claimed its manufacturer covered up evidence about Seroxat's safety. (...)

Heart Defects in Newborns Linked to Brain Abnormalities (Hjertedefekter hos nyfødte linket til misdannelser i hjernen)
medpagetoday.com 8.11.2007
SAN FRANCISCO, Nov. 8 -- The brains of full-term infants with congenital heart disease look like those of premature babies, researchers here said. (...)

The study found that, compared with the normal infants, those with congenital heart disease had a decrease of 10% in the ratio of N-acetylaspartate to choline, which was significant at P=0.003.

They also had a nonsignificant 28% increase in the ratio of lactate to choline (P=0.08), a 4% increase in average diffusivity (P<0.001), and a 12% decrease in white-matter fractional anisotropy (P<0.001). (...)

Syk, eller bare litt redd?
Paul Moxnes, BI-professor og psykologspesialist
dagbladet.no 1.11.2007
Økningen av psykiatriske diagnoser vil gi enorme utgifter og nøre opp under politiske krefter som ønsker å avvikle velferdsstaten (...)

Det finnes nå mer enn 400 mentale lidelser og antallet stiger med hver ny utgave av psykiatriens mest kjente diagnosemanual, DSM. Mange leger og psykologer synes at antallet lidelser nå er blitt uakseptabelt høyt, at det rett og slett er for mye som kalles mentale lidelser som trenger behandling. Legemiddelindustrien har stor økonomisk interesse av å holde vår naturlige evne til å takle angst og uro på et lavt nivå. Det er grunn til å tro at legemiddelindustrien aktivt støtter unødvendige angstdiagnoser. (...)

Freud hadde sannsynligvis rett i at et liv uten sex ikke er sunt for vanlige mennesker, uansett religion eller livssyn. Men det er vanskelig å se at det har sivet noen freudianske tanker over i dagens psykiatriske diagnosemanualer. Her er verken ødipuskompleks eller kastrasjonsangst nevnt. I dag blir heller angstlidelser forklart ut fra en eller flere, til nå uoppdagede, biologiske defekter i hjernen eller hormonsystemet. (...)

Mom files class-action suit
canada.com 5.10.2007
A Vancouver mother has launched a class-action lawsuit claiming the anti-depressant Paxil caused her daughter's heart defect. (...)

The action must be certified before it can go ahead. GlaxoSmithKline, the U.K.-based maker of Paxil, has two weeks to respond to the writ, which claims unspecified damages.

In September 2005, the U.S. Food and Drug Agency issued a warning that detailed the results of a study linking Paxil to birth defects after an increased number of women taking Paxil during the first trimester of pregnancy had babies born with birth defects, including heart problems. (...)

Paxil: “Absolutely do not take it.”
lawyersandsettlements.com 15.9.2007
Westminster, CO: When Rhonda Aldrich found out she was pregnant, she told her doctor she was taking Paxil and asked if there were any concerns about the drug. She notes her doctor said, "There is nothing on the label stating that Paxil will harm the baby." So Aldrich continued taking Paxil. (...)

Paroxetine in the first trimester and the prevalence of congenital malformations
Pharmacoepidemiol Drug Saf. 2007 Aug 30; [Epub ahead of print]
(...) RESULTS: For paroxetine, there were 815 infants among 791 women exposed as monotherapy, and 1020 infants among 989 women exposed as mono- or polytherapy. (...)

AORs for all congenital malformations associated with paroxetine were 1.89 (95%CI 1.20-2.98) for monotherapy, and 1.76 (95%CI 1.18-2.64) for mono- or polytherapy. AORs for cardiovascular malformations associated with paroxetine were 1.46 (95%CI 0.74-2.88) for monotherapy, and 1.68 (95%CI 0.95-2.97) for mono- or polytherapy. CONCLUSIONS: These more detailed paroxetine findings confirm previous findings of analyses of these data among women exposed to all types of antidepressants. The present findings are consistent with other recent results suggesting the possibility of a modestly increased occurrence of congenital malformations following first trimester exposure to paroxetine compared to other antidepressants. (...)

Effects of Antenatal Depression and Antidepressant Treatment on Gestational Age at Birth and Risk of Preterm Birth
Am J Psychiatry 164:1206-1213 (August 2007)
(...) KONKLUSJONER: Bruk av antidepressiva før fødsel var assosiert med kortere svangerskap og økt risiko for at det oppstår for tidlig fødsel. De depressive symptomer, som ble registrert, var ikke assosiert med en slik risiko. Disse resultater tyder på at det er legemidler, snarere enn depresjon, som er indikator for kortere svangerskap. (...) (CONCLUSIONS: Prenatal antidepressant use was associated with lower gestational age at birth and an increased risk of preterm birth. Presence of depressive symptoms was not associated with this risk. These results suggest that medication status, rather than depression, is a predictor of gestational age at birth.)

Paxil Resource Web Site Launched by Williams Kherk
prweb.com 26.6.2007
Williams Kherkher launch a Paxil Resource web site in response to the prescription drug, paxil. (...)

SECRET HELL OF OLYMPICS QUEEN
nypost.com 23.6.2007
(...) "I kept up with [the antidepressant] Paxil, but I was supplementing it with glasses of white wine. Not a good idea . . . To add to my misery, I started smoking." It turned out to be a chemical imbalance in her brain that caused her to "become extremely lethargic . . . sometimes so paralyzed I [didn't] want to get off the couch." (...)

I'M TRAPPED
sundaymail.co.uk 17.6.2007
(...) Diane Smith claims she became agoraphobic when she tried to wean herself off the controversial drug. (...)

Seroxat has been linked to a string of suicides and users say they have suffered serious side effects, including depression. (...)

"I was on it for five years until 2001 when suddenly the psychiatrist took me off it. Then the trouble started.

"I felt suicidal. I get panic attacks and I cannot go out. I can't even go to the supermarket just down the road. I'm a prisoner in my own home. (...)

"The most common symptoms include dizziness, sensory disturbances, sleep disturbance, anxiety and headache."

The drug company have been bombarded by lawsuits in the US.

Donald Schell, 60, from Wyoming, killed his wife, daughter and granddaughter, then shot himself after taking the drug for just two days.

His son-in-law Tim Tobin sued and GSK were ordered to pay £4.5million. (...)

Paxil and Birth Defects (Seroxat og fødselsdefekter)
galvestonbay.injuryboard.com 15.6.2007
(...) Women that took Paxil during their first three months of pregnancy were one and a half to two and a half times more like to have a baby with a serious heart defect as were women that received other antidepressants. This statistic shows that Paxil has extreme influence on babies.

One of the most common side effects of Paxil use is the development of heart problems such as persistent pulmonary hypertension of the newborn (PPHN) in unborn children of women that use the drug. This condition is characterized by the failure of the newborn's lungs to "switch over" to breathing air after birth, which can restrict the amount of oxygen to a baby's delicate body. PPHN can result in a number of serious and potentially life-threatening complications such as hearing loss, heart or kidney failure, and death. This can not go unnoticed by pregnant women. (...)

Some Paxil users find it hard to quit the drug (Enkelte Seroxat-brukere opplever at det er vanskelig å avslutte bruken)
orlandosentinel.com 5.6.2007
When Robert Nishiyama graduated from college seven years ago, anxiety limited his ability to adjust to post-college life. After seeing some commercials for Paxil, an antidepressant, he decided to try it. With only little discussion with a doctor, Nishiyama got the prescription he wanted, and the drug improved his life immediately.

A few years later, he felt well enough to wean himself off the drug. After consulting a doctor, he cut his doses to a pill every other day. But before long, he said, "I started to feel dizzy with electrical zaps shooting through my head." He quickly returned to his original dosage and, two years later, remains resigned to relying on the antidepressant for the foreseeable future.

Nishiyama is one of many who suffer from selective serotonin reuptake inhibitors (SSRI) discontinuation syndrome, a disorder only recently acknowledged by the medical community. SSRIs help with depression and anxiety disorders and are found in prescription drugs, including Paxil and Effexor. A study published in the Journal of Informed Pharmacotherapy in 2001 found that up to 30 percent of people who try to quit the drugs experience "acute discontinuation syndrome." (...)

In 2000, Frank Streicher, then a Paxil user, started quitpaxil .org, a Web site for the millions who claim to be affected by SSRI withdrawal syndrome. (...)

What's chemical castration?
guardian.co.uk 14.6.2007
(...) But the choice of treatment is difficult. Side effects are a problem with hormonal drugs, including, sometimes, the irreversible growth of breasts. Reid spoke in the vaguest of terms, but mentioned both "hormonal medication" and "one of the newer antidepressant drugs" - the SSRIs (selective serotonin reuptake inhibitors), which include Prozac and Seroxat. (...)

Paxil Claims a Short Life
lawyersandsettlements.com 15.5.2007
Omaha, NE: "My wife took Paxil before and during her pregnancy and everything was fine," says Trever Hargitt. "This was going to be our third so we knew what to expect -- or thought we did..." Keagan Hargitt lived only three short weeks due to heart and lung failure. "Now we will never know what our son could have grown up to be." (...)

Paxil, Birth Defects and Autism
lawyersandsettlements.com 11.5.207
Over the past few years, lawyersandsettlements has interviewed dozens of women who took Paxil during their pregnancy and whose babies were born with birth defects. During these interviews, many women told us that their children - usually about age three and upwards -- were also diagnosed with autism.

Mothers reported that some children are high-functioning with mild autism (HFA), while others have been diagnosed with Asperger's syndrome (AS, also known as Asperger Disorder), which is very similar to HFA. AS can exhibit a variety of characteristics and the disorder can range from mild to severe. (...)

Why So Many Scripts?
paxilandbabies.com 9.5.2007
GlaxoSmithKline’s (GSK’s) steady addition to the list of disorders Paxil is supposed to treat and an energetic campaign for its use have lead to an astounding increase in the number of users. There are an estimated 3,000 to 5,000 new users every day. In 2001, doctors wrote about 25 million new prescriptions for Paxil. Some of those were for pregnant women. However, GSK did not tell them or their doctors about the risks of defects, including heart defects, in unborn babies. How does this happen? (...)

Seroxat Link 8 : The Norwegian Adult Suicide Study : 2005
wordpress.com 30.4.2007
I am going to focus on adult suicidality from Seroxat in this post. It is clear from the information in the previous posts how GSK hoodwinked the regulators for a licence to treat adults with Seroxat from 1991 onwards. (...)

Cases of Fen-Phen and SSRI-Related Lung Disorder Rise
By Evelyn Pringle
lawyersandsettlements.com 16.4.2007
(...) SSRIs sold in the US include Prozac, Zoloft, Paxil, Celexa, Lexapro, and the various generic versions of the drugs.

Babies with PPHN, the FDA says, have abnormal blood flow through the heart and lungs, do not get enough oxygen to their bodies and can become very sick and die. (...)

The FDA warning was based on a study in the February 9, 2006, New England Journal of Medicine, led by Dr Christina Chambers, at the University of California in San Diego, which found a 6-fold increased risk of PPH in infants exposed to SSRIs after the 20th week of pregnancy. (...)

Prescription For Disaster
video.google.com (1 hr 32 min 56 sec - Oct 23, 2006)
www.garynull.com

The Drugging of our Children (Gary Null)
video.google.com (Gary Null 1 hr 43 min 4 sec - Oct 20, 2005)
www.garynull.com

Former nurses union CFO sentenced (Tidligere regnskapssjef i sykepleierforening dømt)
timesunion.com 30.3.2007
ALBANY -- The former chief financial officer of the state's largest nurses union was sentenced today to 3 1/3 to 10 years in prison and ordered to pay back the money he pilfered over several In January, John T. Daley pleaded guilty to second-degree larceny before Albany County Judge Thomas Breslin. He admitted writing hundreds of the union's checks totaling $1.2 million, the amount he was ordered to repay to the union and its insurance companies during sentencing. He could have faced up to 25 years behind bars.

Daley was terminated from his $130,000-per-year job after the fraud came to light.

Hans advokat, James E. Long, sa fredag at Daley allerede er bedring. Daleys handlinger skyldes ifølge ham bivirkninger fra det reseptbelagte legemidlet Seroxat (Paxil). (His lawyer James E. Long said Friday that Daley has already started to make restitution. He blamed the side effects of the prescription drug Paxil for Daley's actions.)

Drugs inquiry thrown into doubt over members' links with manufacturers (Det er sådd tvil om legemiddelgranskning grunnet medlemmers forbindelser til produsenter)
guardian.co.uk 17.3.2007 (The Guardian)
Drugs inquiry links to makers

The credibility of a government inquiry intended to settle the controversy surrounding widely prescribed anti-depressant drugs was thrown into question yesterday by revelations that most of the members have shareholdings or other links to the manufacturers.

The "intensive review" of the side effects of Seroxat, Prozac and other antidepressants of the SSRI (selective serotonin reuptake inhibitor) class was announced in the House of Commons by health minister Hazel Blears in December last year. It was a response to mounting concern from large numbers of patients who say they have been unable to come off Seroxat because of severe withdrawal symptoms. (...)

Paxil Delivered Death Certificate
lawyersandsettlements.com 15.3.2007
Whitby, ON: Due to a bad car accident in 1998 that led to depression and anxiety, Lisa Goring was prescribed Paxil. She became pregnant in 2001 and her doctor said it was safe to stay on this SSRI. Most doctors today know otherwise. (...)

Two of the four CSM scientists, Michael Donaghy, a reader in clinical neurology from Oxford University, and David Nutt, professor of psychopharmacology at Bristol University, hold shares in GlaxoSmithKline, manufacturers of Seroxat. They have to leave the room when Seroxat is discussed, although they stay for debate on the SSRI drugs as a class.

Prof Nutt and the invited expert, David Baldwin, senior lecturer in psychiatry at Southampton University, jointly fronted the promotional press launch of Seroxat after it won a licence to be prescribed for social anxiety disorder and was popularly dubbed the "shyness pill".

Charles Medawar, of the watchdog organisation Social Audit, is seeking a reference to the ombudsman over the composition of the review. (...)

MP in call for halt to use of anti-depressant (Parlamentsmedlem ber om at bruk av atidepressiva stanses)
thecourier.co.uk 7.3.2007
ET PARLAMENTSMEDLEM FRA DUNDEE ber om at det kontroversielle antidepressiva Seroxat ikke brukes på nye pasienter på bakgrunn av de økende bevis som linker det til selvmord. (A DUNDEE MP is calling for the controversial anti-depressant Seroxat to be suspended for all new patients in the light of growing evidence linking the drug to suicidal tendencies.)

Dundee East MP Stewart Hosie met the medicines trade body, the Association of British Pharmaceutical Industries, to outline his concerns about the drug.

A recent US Food and Drug Administration report found a six-fold increase in the risk of suicidal thoughts and acts in children and a three-fold increase in adults after Seroxat treatment.

It is the latest in a long line of damning reports over the drug’s dangerous effect on an unacceptably high number of adults and children, and Mr Hosie has criticised ministers for “dragging their heels over the strong evidence regarding Seroxat.” (...)

Britney får ikke besøke barna
vg.no 5.1.2008
Stjernen tvangsinnlagt etter gårsdagens drama
(VG Nett) Retten har bestemt at Kevin Federline (30) får eneomsorgen for sønnene. Men Kevins advokat er ikke fornøyd. (...)

Ifølge Daily Mail skal Britney være under en såkalt «5150 hold»-diagnose - som betyr at helsepersonell anser henne som til fare for seg selv eller andre. (...)

Spears Popped Antidepressants Before VMAs
hollywood.com 13.9.2007
(...) HOLLYWOOD - Britney Spears was fed antidepressant drugs minutes prior to her lackluster performance at the MTV Video Music Awards on Sunday after a heated feud with a hair stylist.

The tormented pop star angrily disapproved of the chosen hairstyle for her comeback at the Las Vegas ceremony and flew into "blind panic," according to reports.

A doctor was dispatched to the Palms Casino resort to give the star prescription drugs. (...)

Is Britney Spears Suffering From Postpartum Depression?
starpulse.com 28.2.2007
(...) Fortunately, Shields overcame the condition with counseling and the anti-depressant Paxil, and wrote about her experiences in the 2005 book "Down Came The Rain." (...)

GSK accused of covering up Seroxat side effects
newslocale.org 27.2.2007
British pharmaceutical company GlaxoSmithKline Inc had distorted clinical results of its antidepressant Seroxat which causes suicidal tendencies in teenagers who were prescribed with the tablet, a BBC investigation said. (...)

Robbie Williams is hooked on anti-depressants Seroxat and Xanax, and the painkiller Vicodin, it has been reported
pr-inside.com 14.2.2007
(...) Robbie's fears of becoming addicted to prescription drugs were apparent in the lyrics of 'Good Doctor' - which features on latest album 'Rudebox'. (...)

Drug turned Janice's life into living nightmare'
sunderlandtoday.co.uk 16.2.2007
(...) She also received help and support from the Council for Involuntary Tranquillisation and Addiction (CITA).

She added: “I want people to know they can get through it, but more really needs to be known about what Seroxat can do.”

A recent BBC Panorama programme claimed people can get hooked on the drug, while pop star Robbie Williams, who recently admitted himself into a U.S. rehab centre is also alleged to have used the anti-depressant.

A spokeswoman for CITA said: “We believe withdrawal from this drug can be terrible. Whatever good was done by the person taking it is undone when they try to get off it.” (...)

It wasn’t fat - it’s my hormones (Det var ikke fett - det var mine hormoner)
thesun.co.uk 6.10.2010
ROBBIE WILLIAMS lost all motivation during his three years in the wilderness.

Even a visit from Mr Motivator would have failed to kickstart him.

He piled on the pounds, grew a scruffy beard and holed up in his LA mansion watching DVDs, playing online pool and obsessing over aliens.

He thought he had got plain lazy and blamed his dead batteries on past excesses with drugs and booze.

But now Robbie has told how a recent visit to a doctor revealed it was all a HORMONE PROBLEM - for which he is now on medication. (...)

Robbie Williams undergoing treatment for mysterious illness (Robbie Williams får behandling for mystisk sykdom)
celebrities-with-diseases.com 17.10.2010
Robbie Williams says he is suffering from a mysterious illness, which is to blame for the limited success of his comeback album Rubebox. According to www.dailymail.com, the singer, who had taken his depressive state for granted earlier,woke up to realise that it was more than just a state of mind. He recently said in an interview : “I thought I was lethargic and depressed as a person. I thought that was my make-up.” (...)

Robbie Williams is hooked on anti-depressants Seroxat and Xanax, and the painkiller Vicodin, it has been reported
pr-inside.com 14.2.2007
(...) Robbie's fears of becoming addicted to prescription drugs were apparent in the lyrics of 'Good Doctor' - which features on latest album 'Rudebox'. (...)

What drove Robbie to rehab (Hva drev Robbie til rehabilitering)
thesun.co.uk 14.2.2007
(...) Hooked ... Seroxat, a controversial anti-depressant and prescription pills

However, last night his mum Jan, 56 — a drugs counsellor — said going into rehab was “the best present he could give himself”. (...)

The singer finds it impossible to get to sleep until 4 or 5am due to insomnia and is on sleeping pills. He is hooked on the powerful and controversial anti-depressant Seroxat, which has been linked to suicidal tendencies in teenagers. (...)

WILLIAMS' DRUG DEMONS
contactmusic.com 14.2.2007
(...) The newspaper writes, "The singer finds it impossible to get to sleep until 4 or 5am due to insomnia and is on sleeping pills. He is hooked on the powerful anti-depressant Seroxat, which has been linked to suicidal tendencies in teenagers. (...)

Why you should never trust new wonder drugs (Hvorfor du aldri bør stole på nye vidundermiddel)
dailymail.co.uk 6.2.2007
A drug company was last week accused of concealing evidence about the safety of the antidepressant Seroxat. According to leading psychiatrist Professor David Healy, this is just the latest in a string of cases where patients and medical professionals have been misled about a drug's adverse effects. (...)

It has never taken any action against the academics who make fraudulent claims in ghostwritten articles, nor doctors working for the companies who repeat such claims, even when they have been shown to be untrue.

So the only other body to turn to is the General Medical Council, whose job it is to investigate the conduct of doctors - but it has shown no inclination to act. (...)

Glaxo Faces Allegations
cleveland.injuryboard.com 1.2.2007
Pharmaceutical giant GlaxoSmithKline faces further accusations concerning disclosure of failed clinical trials related to the antidepressant Seroxat or Paxil. Some studies reveal that these types of anti-depressants should not be used on teenagers, due to an increase in suicidal behavior when the drugs are prescribed. The new accusations suggest that the drug manufacturer new about the link between the drug and suicidal behavior in teenagers and yet tried to market the drug as a beneficial anti-depressant for kids under 18. (...)

BBC and GSK battle over Seroxat
rsc.org 30.1.2007
UK pharmaceutical giant GlaxoSmithKline, which has spent the past few years fighting off accusations of risks associated with its market-leading antidepressant Seroxat, has rejected fresh claims that it improperly withheld medical trial information in the 1990s. (...)

The emails reported by Panorama came to light as part of ongoing fraud trial investigations in the US. The MHRA's Criminal Investigation Unit is also investigating the issues surrounding withheld Seroxat clinical trial data, though a spokesperson said this had not yet been referred to the police. (...)

Glaxo back in the frame
thisismoney.co.uk 30.1.2007
The Seroxat scandal refuses to go away for GlaxoSmithKline. Two years after Britain's biggest drug firm settled with the then New York Attorney General Eliot Spitzer and 49 American states the company is still being accused of hiding critical data showing that the anti-depressant is linked to suicide in teenagers. (...)

GSK rebuts Panorama claims it distorted Seroxat trial results
guardian.co.uk 30.1.2007
GlaxoSmithKline, the UK's biggest pharmaceutical firm, yesterday labelled as "defamatory" allegations in a Panorama programme that it had distorted trial results for Seroxat, its best-selling antidepressant. (...)

Visste at lykkepillen er farlig
dagbladet.no 29.1.2007
Bruken av anti-depressivaen Seroxat, også kjent som lykkepille, har lenge vært omdiskutert. Nå viser det seg at også produsenten visste at legemiddelet ikke virket og i noen tilfeller er farlig. Likevel markedsførte de Seroxat som det beste alternativet i behandlingen av depressjoner, skriver bbcnews.

Legemiddelprodusenten GlaxoSmithKline (GSK) egne kliniske tester viste at Seroxat ikke hadde den effekten de ønsket, og prøvde også å tåkelegge forskning som tydet på at bruk av middelet kan føre til selvmord blant barn.

Det er GSKs interne papirer som avslører selskapet. I USA har flere familier gått til søksmål mot GSK og krever erstatning, og i den sammenheng er GSKs konfidensielle, interne dokumenter åpnet. (...)

Drug giant 'covered up safety fear on Seroxat'
dailymail.co.uk 29.1.2007
A drugs firm covered up vital evidence about the safety of an anti-depressant linked to a string of suicides, it was claimed last night. (...)

Storbritannias største legemiddelfirma prøvde å skjule selvmordsfaren ved medisiner mot depresjoner..
side2.no 29.1.2007
Legemiddelfirmaet GlaxoSmithKline prøvde å bevise at legemiddelet «Seroxat» fungerte for deprimerte barn til tross for at kliniske undersøkelser viste det motsatte. (...)

An investigation into whether Britains biggest drug company deliberately misled doctors
libcom.org/news/tv-times-27-jan-2-feb-2007-27012007
Mon 29 January - 8.30 - 9pm - BBC1 - Panorama - Secrets of the Drugs Trials
An investigation into whether Britains biggest drug company deliberately misled doctors into prescribing Seroxat for depressed teenagers without any evidence to prove its efficacy to treat this patient group. (Given this industries penchant for illegally testing its wares on Third World citizens, illegally dumping out-of-date and lethal drugs in deprived countries for the tax breaks, deliberately letting vulnerable people die for the sake of a few pence profit and carrying out acts of corporate murder when their "reputation" is threatened this would be hardly be surprising.) (...)

Reputations for sale?
Editor's choice
Fiona Godlee, editor, BMJ
BMJ 2007;334 (27 January)
This week, BBC's Panorama programme again revisits the controversy surrounding the SSRI Seroxat. Its 2002 investigation into reports of adverse events from Seroxat prompted 67 000 people to contact the BBC, forcing a rethink of the safety data. Now GlaxoSmithKline faces legal action and, if found culpable, the possibility of huge payouts to thousands of patients.

As Joe Collier explains in his preview of this week's Panorama, to be aired on Monday 29 January (doi: 10.1136/bmj.39104.771597.59), the focus this time is on the interplay between industry and the forces that should counter what he calls "the adverse effects of drug companies." Panorama's account of GlaxoSmithKline's successful attempts to market Seroxat for use in children, despite the fact that its own published trial found evidence of serious adverse effects and failed to show benefit, is fascinating but depressingly familiar. The Vioxx story, told last week (BMJ 20 January, p 120), appears to have all the same hallmarks, including the paying of opinion leaders and ghost writers to talk up a drug when the evidence can't speak for itself.

Let's be clear what is and is not acceptable. There is nothing wrong with getting help from medical writers, provided they and their source of funding are clearly acknowledged. In fact the BMJ agrees with Keith Dawes (doi: 10.1136/bmj.39104.595463.94), that medical writers are generally a good thing (see Resources for authors on bmj.com http://resources.bmj.com/bmj/authors). Nor is there anything wrong with academics or clinicians working with industry, provided they remain personally accountable for everything they say. What is clearly wrong is writers, academics, or clinicians concealing under their coat tails an army of company spin doctors intent on distorting the scientific record.

Legislation is not going to happen soon—the powerful industry lobby will make sure of that. Regulation is still inadequate (David Healy, BMJ 2006;333:92-5), although the US Food and Drug Administration is at last tightening up on postmarketing surveillance (doi: 10.1136/bmj.39104.352616.DB). So what can we do to change the blind-eye culture of medicine? In the interests of patients and professional integrity I suggest intolerance and exposure. As Joe Collier says, we shouldn't have to rely on investigative journalists to ask the difficult questions. So at meetings, why not slow hand clap any speaker who does not begin their talk with a sentence or slide declaring their conflicts of interest? And if journals discover authors who are guests on their own papers, they should report them to their institution, admonish them in the journal, and probably retract the paper. Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking. (...)

Paxil-Related Lawsuits in the United States
legalblog.resourcesforattorneys.com 22.1.2007
Recently, it has been reported that the use of Paxil, an antidepressant medication, has caused a condition known as akathisia; which is a condition of severe inner restlessness. This akathisia has lead to increased suicidal and violent thoughts leading to the injury, harm or death to many of the patients taking Paxil. Because of the increase in injury and death, many new lawsuits against the GlaxoSmithKline Company, the manufacturers of the drug, Paxil, have been opened and reported. Paxil was never approved or recommended by the American Food and Drug Administration and many doctors went forward and prescribed Paxil to patients under eighteen years old and to those who were pregnant or nursing based solely on their professional judgment. Today, many of these patients have suffered extreme side effects, including suicidal death as a result of taking the prescribed Paxil. (...)

Thalidomide redux (Thalidomid gjenoplives)
Pregnant women still at risk (Gravide kvinner fremdeles utsatt for risiko)
commonground.ca (December 2006)
(...) Back in August 2004, both Health Canada and the US FDA issued warnings to pregnant women to withdraw slowly from their antidepressant medication in the third trimester. There were reports of women taking SSRI antidepressants – drugs like Prozac, Paxil, Zoloft and Effexor – giving birth to newborns with withdrawal symptoms. Withdrawal? Yes. One of the major problems with all the SSRIs is that withdrawal can be extremely difficult, even excruciating for some patients. This is certainly not new. The withdrawal effects, duly noted elsewhere were simply being logically applied in a new place: in unborn children. (See Health Canada’s August 9, 2004, advisory of potential adverse effects of SSRIs and other antidepressants on newborns at (www.hc-sc.gc.ca/english/protection/warnings/2004/2004_44.htm) (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: Thalidomide (Thalidomid) informasjon vs kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

(Anm: Fosterskader (legemiddelinduserte) (mintankesmie.no).)

[A case of Parkinson's disease with neuroleptic malignant syndrome induced by paroxetine]
Rinsho Shinkeigaku. 2006 Aug;46(8):575-8.
We present a first case of Parkinson's disease with neuroleptic malignant syndrome by Paroxetine, one of the selective serotonin reuptake inhibitor (SSRI). (...)

First South Carolina Paxil Lawsuit
abcnews4.com 28.12.2006
SC - The maker of the anti-depressant Paxil is being sued by a South Carolina couple who believes the drug caused their daughter's birth defect. It is likely the first lawsuit of its kind filed in this state.

Taylor Dismuke looks like any other 6-year-old girl, but she is living with a heart malformation that will affect her for a lifetime. Her mother, Kimberly Dismuke said, "She won't be able to participate in sports. She won't be able to participate in dancing, cheerleading, gymnastics, anything like that." (...)

Paxil saves him from prison (Slipper fengsel grunnet Seroxat)
sptimes.com 20.11.2006
Early edition: Judge agrees antidepressant was partly responsible for Jabil worker embezzling $1.8 million. (...)

'Paxil defense' embezzler avoids prison
seattlepi.nwsource.com 21.11.2006
(...) "It's a good day at our house," said his wife, Leslie.

Paxil's box carries a warning that anyone using the drug should be monitored for signs of agitation, irritability, suicidal thoughts or other unusual changes in behavior. It also warns that any psychoactive drug may impair judgment or thinking. Paxil is manufactured by GlaxoSmithKline. (...)

Out of state Paxil class member objects to Madison County settlement
madisonrecord.com 10.11.2006
Madison County Associate Judge Ralph Mendelsohn allowed a Florida woman to intervene in a recently settled Paxil class action over the objection of attorney Stephen Tillery.

But Mendelsohn, who held a hearing Wednesday, denied her motion to vacate the anti-suit injunction.

Barbara Jane Rose of Florida filed for leave to intervene so she could ask Mendelsohn to vacate his Oct. 6 order which stops competing suits against GlaxoSmithKline, the maker of Paxil.

When issuing the injunction Mendelsohn wrote, "The Court finds that the prosecution of other actions concerning the claims released by this settlement would result in fraud, gross wrong, or oppression and equity requires such actions be enjoined to prevent manifest wrong and injustice." (...)

Attorneys plan to file objections in Madison County's Paxil settlement
stclairrecord.com 3.11.2006
Attorneys in competing class action suits against GlaxoSmithKline's anti-depressant drug Paxil plan to file objections to a recent Madison County settlement.

According to several legal sources who asked not to be identified, class action attorneys from across the country are upset with the Madison County class action settlement because the amount is not sufficient to compensate all those who will have a claim.

GlaxoSmithKline (GSK) agreed to pay $63 to settle all future claims in the Madison County case. GSK was accused of promoting Paxil and Paxil CR for prescription to children under 18 while withholding negative information about the medications safety and effectiveness. (...)

Glaxo Agrees to Pay $63.8 Million in Lawsuit
nytimes.com 2.11.2006
— GlaxoSmithKline has agreed to pay $63.8 million to settle a lawsuit accusing it of promoting its antidepressant Paxil for use by children and adolescents while withholding negative information about the drug’s safety and effectiveness.

The lawsuit was a class action. United States residents who bought Paxil or Paxil CR, a controlled-release version of the drug, for their children could receive full refunds if they have records of their purchases. (...)

GlaxoSmithKline Reaches Paxil Settlement (GlaxoSmithKline inngår Seroxat-forlik)
forbes.com 1.11.2006
GlaxoSmithKline PLC has agreed to pay $63.8 million to settle a lawsuit's claims that it promoted its antidepressant drug Paxil for use by children and adolescents while withholding negative information about the medication's safety and effectiveness.

Members of the class, including all U.S. residents who bought Paxil and Paxil CR, a controlled-release version of the drug, for their children each could get full refunds if they have records of their purchases. Anyone without such documentation can get $15 returned to them. (...)

Seroxat update
bbc.co.uk 14.9.2006
Shelley Jofre gives an update on her investigation into the antidepressant Seroxat. Shelley has currently made three films about the drug.

Seroxat and the other SSRI antidepressants (including Prozac, Lustral and Ciprimil) may provoke violence in a small number of people who take them, according to a paper published today on the Public Library of Science Medicine website.

The study - which focused primarily on Seroxat - looked at clinical trial data and reports of adverse effects and found possible links between SSRI antidepressants and violent behaviour.

Back in October 2002, Panorama broadcast Secrets of Seroxat. (...)

Parents Enraged At Glaxo Over Paxil Birth Defects
bestsyndication.com 7.9.2006
On July 28, 2006, a lawsuit was filed in Philadelphia against GlaxoSmithKline, on behalf of Adrian Vasquez, an infant born on April 19, 2004, with life-threatening congenital heart defects as a result of his mother having been prescribed Paxil during pregnancy. (...)

The Vasquez family lawsuit alleges in part, that Glaxo was negligent in, "Failing to fully disclose the results of the testing and other information in its possession regarding the possibility that Paxil can interfere with the proper development of an unborn fetus."

The complaint specifically charges that, "GSK promoted Paxil for use with pregnant women despite the fact that GSK knew or should have known that Paxil is associated with an increased risk of congenital abnormalities."

The FDA initially approved Paxil in 1992, and due to an aggressive marketing campaign by Glaxo, it quickly became one of the most popular drugs worldwide. Paxil belongs to the class of antidepressants known as the selective serotonin reuptake inhibitors (SSRIs).

However, over the past couple of years, studies have linked Paxil to a variety of serious birth defects. In September 2005, Glaxo sent out a "Dear Doctor letter" advising healthcare professionals of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI were more likely to have an infant with omphalocele, an abnormality in which the infant's intestine or other abdominal organs protrude from the navel.

The strongest effect was reported with Paxil, accounting for 36% of all SSRI exposures. (...)

Rapid Responses to:
ANALYSIS AND COMMENT:
David Healy
Did regulators fail over selective serotonin reuptake inhibitors?
BMJ 2006; 333: 92-95 [Full text]

Rapid Responses:
Read all Rapid Responses
Seroxat Petition Tabled by Stewart Hosie MP for Dundee East June 21st 2006
Derek D Scott, et al.
bmj.com, 10 Jul 2006 [Full text]

House of Commons debates
Stewart Hosie (Dundee East, Scottish National Party) Link to this | Hansard source
Petitions - Seroxat
I take enormous pleasure in presenting a petition on behalf of my constituent, Mr. D. Scott, from Dundee, who calls for the precautionary principle to apply to the prescription of Seroxat. (...)

Fatal neuroleptic malignant syndrome in a previously long-term user of clozapine following its reintroduction in combination with paroxetine
Aging Clin Exp Res. 2006 Jun;18(3):266-270
A 77-year-old patient with initial behavioral and psychological symptoms of dementia was treated with clozapine (50 mg/daily). Since no clinical benefit was apparent, clozapine was discontinued after six weeks and the patient started on paroxetine (20 mg/daily). After three weeks on paroxetine, he was given another trial of clozapine at a starting dosage of 25 mg/daily. While clozapine had previously been well tolerated, this time he rapidly developed fever, mental confusion, lethargy, muscle spasms and rigidity. The diagnosis of neuroleptic malignant syndrome was delayed, because there was no leukocytosis and serum creatine phosphokinase was initially not elevated. Subcutaneous apomorphine was then given but, after an initial improvement, the patient developed a multiple organ failure syndrome and died. (...)

A rare case of combined syndrome of inappropriate antidiuretic hormone secretion and Fanconi syndrome in an elderly woman
Am J Kidney Dis. 2006;48(1):155-8 (July)
Department of Nephrology and the Kidney and Dialysis Center, Shonan Kamakura General Hospital, Yamazaki, Kamakura, Japan.
An 83-year-old Japanese woman was admitted to our hospital with severe hyponatremia (sodium, 108 mEq/L [108 mmol/L]), hypokalemia, hypochloridemia, hypocalcemia, hypophosphatemia, and hypouricemia. Despite low plasma osmolarity (232 mOsm/kg [232 mmol/kg]), urine osmolarity (320 mOsm/kg) was greater than that of plasma, and she had increased urinary sodium excretion (88 mEq/L [88 mmol/L]) and an unsuppressed high plasma level of antidiuretic hormone (ADH; 5.5 pg/mL [5.1 pmol/L]). These findings indicated that she had syndrome of inappropriate ADH secretion (SIADH). In addition, she had a generalized reabsorption defect of the proximal tubules, including decreased tubular reabsorption of phosphate, increased fractional excretion of uric acid, glycosuria despite a normal blood glucose level, and panaminoaciduria. Thus, combined SIADH and Fanconi syndrome was diagnosed. The cause was thought to be the antidepressant paroxetine, which is a selective serotonin reuptake inhibitor (SSRI). Several of the abnormal values resolved within 1 week after discontinuation of this drug. Although the precise mechanism responsible was not elucidated, we report an extremely rare case of combined SIADH and Fanconi syndrome, probably caused by short-term SSRI therapy. (...)

Paroxetin kan öka självmordsrisken hos vuxna
Läkemedelsvärlden 2006(5) (Maj)
Vuxna med egentlig depression har en liten, men signifikant ökad risk för självmord och självmordstankar vid behandling med paroxetin. Störst är risken bland yngre vuxna, upp till 30 års ålder, visar en ny metaanalys.

SSRI De senaste åren har ökad självmordsrisk vid behandling med SSRI debatterats flitigt. Myndigheter i både USA och Europa har varnat för en ökad risk för självmord bland barn och ungdomar som behandlas med SSRI, men om riskökningen även gäller vuxna har varit oklart, då metaanalyserna har pekat i olika riktning. Nu har Glaxosmithkline (GSK), företaget bakom paroxetin, tagit saken i egna händer och gjort en egen metaanalys.

Analysen omfattar resultat från placebokontrollerade kliniska prövningar av paroxetin på knappt 15 000 vuxna med olika psykiatriska diagnoser, till exempel depression, panikångest, generaliserad ångest och tvångssyndrom.
Resultaten visar att unga vuxna (18-24 år) som fick läkemedlet hade högre risk för suicidalt beteende än dem som fått placebo, detta oavsett studerad diagnos.

Vid egentlig depression var frekvensen av suicidalt beteende signifikant högre för paroxetin-gruppen som helhet, i alla åldrar.

GSK och den amerikanska läkemedelsmyndigheten FDA poängterar dock att resultaten bör tolkas med försiktighet eftersom risken i absoluta tal var mycket liten: elva rapporterade självmordsförsök bland 3455 som fått paroxetin för depression, jämfört med ett bland 1978 patienter i placebo-gruppen.
Majoriteten av självmordsförsöken återfanns i gruppen "yngre vuxna", 18-30 år.
Företaget har uppdaterat den amerikanska produktinformationen, och skickade under fredagen ut ett varningsbrev till amerikanska läkare.

Sedan tidigare har SSRI-läkemedel en varningstext om ökad risk för självmord hos barn och ungdomar.

Nu utökas varningen, och läkare uppmanas att vara observanta på att både vuxna och barn med egentlig depression kan få en försämring av sina depressionssymtom och/eller självmordstankar. (...)

Manufacturer admits increase in suicidal behaviour in patients taking paroxetine
BMJ 2006;332:1175 (20 May)
GlaxoSmithKline announced last week that they had found an increase in suicidal behaviour in adults taking paroxetine (Paxil/Seroxat) compared with placebo. The conclusion was based on an analysis of patients aged 18-64 years in clinical trials.

The researchers found that 0.32% (11/3455) of people taking paroxetine for depression attempted suicide compared with 0.05% (1/1978) of depressed patients taking placebo (odds ratio 6.7, 95% confidence interval 1.1 to 149.4; P=0.058). One person in the paroxetine group successfully killed themselves. GlaxoSmithKline said the data should be interpreted with caution and that the “overall risk-benefit of paroxetine in the treatment of adult patients with MDD [major depressive disease] remains positive.” (...)

Antidepressant May Raise Suicide Risk
nytimes.com 12.5.2006
After analyzing data from clinical trials, GlaxoSmithKline has sent letters to doctors warning that its antidepressant drug Paxil appears to increase the risk of suicide attempts in some young adults.

The company said it had changed the labeling on the drug to reflect the finding of the study, which analyzed clinical trial data involving some 15,000 people. The study found that reported suicide attempts were rare but significantly more common in adults who took the drug for depression than in those who received placebo pills.

The Glaxo researchers reported only one suicide in the trials, a number so small it says nothing about the drug's risk, experts said. (...)

Anklager om fusk med Novo-forskning
dr.dk 5.5.2006
En norsk professor beskylder Novo Nordisk for at have skjult oplysninger om selvmordsforsøg i forbindelse med depressionspillen Seroxat.

Det kommer frem i programmet "Den Mørke Side", der sendes lørdag på P1. Programmet er lavet i samarbejde med Forbrugerrådets blad Tænk, skriver Politiken.

Professor i farmakologi, Ivar Aursnes, har forsket i det materiale, som Novo Nordisk i 1990 sendte til myndighederne for at få godkendt Seroxat.

Aursnes anklager Novo Nordisk for i materialet bevidst at have forsøgt at skjule data om flere selvmordsforsøg i den gruppe, som tog Seroxat.

Risiko for hjertemisdannelser hos barnet ved bruk av paroksetin i svangerskapet
legemiddelverket.no 13.3.2006
Bruk av paroksetin tidlig i svangerskapet synes å gi en liten økt risiko for hjertemisdannelser hos barnet. Statens legemiddelverk anbefaler at paroksetin ikke gis til gravide i løpet av svangerskapets første tre måneder, eller til kvinner som prøver å bli gravide, uten at det er nødvendig av medisinske grunner.

Studier tyder på at risikoen er mindre enn 2 % dersom mor har brukt paroksetin, sammenlignet med en forventet risiko på ca. 1 % i den generelle befolkningen. (...)

(Anm: en økning av risiko for hjertemisdannelser fra 1 % til nærmere 2 %, kan ikke karakteriseres som en "en liten økt risiko".)

Neurotropic viruses are associated with cerebral palsy (Neurotropiske viruser og cerebral parese)
BMJ 2006;332 (14 January)
Perinatal exposure to neurotropic viruses is associated with a higher risk of cerebral palsy. In a laboratory based case-control study using dried blood from the newborn screening cards of 443 children with cerebral palsy and 883 controls, Gibson and colleagues (p 76) tested for viral nucleic acids from enteroviruses and herpesviruses and found a prevalence of herpes B group viruses of 12.1% for cerebral palsy cases and 7.6% for controls. The high prevalence of viral nucleic acids in the control group (39.8%) suggests that triggers are needed before brain damage can occur, say the authors. (...)

(Anm: cerebral parese; lammingar, stiv eller altfor slakk muskulatur, stundom vinglande rørsler, talevanskar eller andre stasjonære eller litt skiftande neurologiske plager særleg med motorikken, stundom med årsak i skadar under vanskeleg eller for tidleg fødsel eller oftare uklare skiplingar i hjernen si utvikling, kan skuldast ulike forandringar i hjernevevet men helst periventrikulær leukomalasi som ev kan påvisast med ultralyd; jf saksegang, atetose. EN cerebral palsy. ET [gr parienai la falla]. Kilde: Norsk medisinsk ordbok.)

Using Quality-of-Life Measurements to Predict Patient Satisfaction Outcomes for Antireflux Surgery
Arch Surg, 2004; 139: 621 - 626 (Jun 2004)
...fatigue syndrome, or fibromyalgia, or when I see on the medication list sertraline hydrochloride or paroxetine, a red flag goes up....

Bivirkningskasus: Mulig interaksjon mellom warfarin og paroksetin.
relis.no 16.1.2006 (RELIS – regionale legemiddelinformasjonssentre)
Introduksjon
Samtidig bruk av paroksetin og orale antikoagulasjonsmidler kan føre til økt antikoagulativ aktivitet og blødningsrisiko. Paroksetin bør derfor brukes med forsiktighet hos pasienter som behandles med orale antikoagulasjonsmidler (1-3).

Pasientkasus
En pasient i slutten av 60 - åra, hadde brukt warfarin i noen år, da et akutt subduralt hematom oppsto. Det er mulig at et lett traume mot hodet dagen før hendelsen kan ha vært en medvirkende årsak. Pasienten brukte også paroksetin, men det er uvisst når behandlingen startet. INR ble målt til 3,7 halvannen uke før hendelsen og ble målt til over 8,1 ved ankomst til sykehuset (ønsket INR - intervall for pasienten: 2,0-3,0). Warfarin ble seponert, og pasienten ble gradvis restituert.

Diskusjon
Insidensen av blødninger hos pasienter som behandles med warfarin er rapportert å være fra 2 til 48 % (4). Blødninger som følge av uønsket sterk virkning av warfarin blir rapportert til Statens legemiddelverk gjennomsnittlig 70 ganger per år (5). Ved en gjennomgang av alle norske bivirkningsmeldinger i perioden 1990-2000 fant man 713 meldinger hvor warfarin var relatert til blødninger. Cerebrale blødninger var rapportert i 57 % av meldingene (5).

I en case-control studie ønsket man å kartlegge risikoen for intrakranial blødning hos warfarinbrukere, spesielt hos eldre. Resultatene fra denne studien viste at en økning i INR over 2,0 økte risikoen for en intrakranial blødning. Høy alder var også en risikofaktor og risikoen for subduralblødning ble doblet for hver aldersøkning på 10 år (4). I en annen studie med 68 pasienter og 204 kontroller fant man at risikofaktorer som signifikant predisponerer for intracerebral blødning ved behandling med warfarin inkluderer INR over 4,5, kort varighet på behandlingen (1 år eller mindre), alkoholmisbruk og iskemisk hjertesykdom (4).

I følge preparatomtalen for Marevan ® er blødning klassifisert som en vanlig bivirkning (>1/100). Warfarin er en vitamin K – antagonist som blokkerer leverens syntese av koagulasjonsfaktorene II, VII, IV og X. Blodets konsentrasjon av disse komponentene nedsettes og koagulasjon hemmes (2).

Økt blødningstendens er en kjent, men sjelden (<1/1000) bivirkning av paroksetin og en klasseeffekt for alle SSRIene. Mekanismen antas å være hemming av trombocyttenes opptak av serotonin (5-HT), noe som fører til nedsatt trombocyttfunksjon (1, 6).

Konklusjon
I dette tilfellet anser RELIS det som sannsynlig at det er en årsakssammenheng mellom pasientens bruk av warfarin og det oppståtte hematomet. Det kan heller ikke utelukkes at en interaksjon mellom warfarin og paroksetin har gitt økt blødningsrisiko. Det er viktig at terapikontrollen skjerpes ved oppstart og seponering av SSRIer når pasienten også bruker warfarin. Meldingen klassifiseres som alvorlig. (...)

Study hints at Paxil tie to birth defects (Studie antyder at Seroxat er knyttet til fødselsdefekter)
USA TODAY 27.9.2005
A retrospective study found increased numbers of babies born with birth defects to women who were taking Paxil during the first trimester of pregnancy, as compared with women on other antidepressants, according to the FDA and the company. (...) (Ifølge FDA og firmaet viste en retrospektiv studie et økt antall spedbarn med fødselsdefekter hos kvinner, som tok Seroxat (Paxil) i løpet av det første trimester av svangerskapet, sammenliknet med kvinner på andre antidepressiva.)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

3.000 jenter fikk antidepressiva
Vårt Land 28.9.2005
Kvinner står for to tredjedeler av bruken av antidepressiver.

Forbruket av antidepressiver er høyest hos kvinner. Nesten 3.000 jenter mellom 15 og 19 år fikk i fjor såkalte «lykkepiller» på resept. (...)

«A pill a day keeps the doctor away»
Tidsskr Nor Lægeforen 2005; 125: 2448 (8.9.2005)
Hun hadde angst for å kjøre gjennom lange tunneler og nevnte det under en konsultasjon med sin primærlege. Svaret var en resept på lykkepillen Seroxat uten opplysninger om bivirkninger og med mangelfull oppfølging fra legens side.
Dette høres ut som en dårlig legevits, men det er dessverre en historie fra det norske helsevesen anno 2005. (...)

Drug 'can trigger suicide in adults'
Guardian 22.8.2005
Commonly used modern antidepressants can cause adults as well as children to attempt suicide, a new study says.

An 18-month inquiry convened by the Medicines and Healthcare Regulatory Authority (MHRA) in the UK banned the use of the drugs, known as the SSRIs (selective serotonin reuptake inhibitors) in children and adolescents.

Last December it said the drugs were over-prescribed though they could safely be used by adults.

But a study published today in the online journal BMC Medicine casts doubt on the MHRA's findings. One of the manufacturers, the British company GlaxoSmithKline, which makes the bestselling Seroxat, did not submit its original detailed data from clinical trials of the drug to the regulator, said the Norwegian author of the report, Ivar Aursnes.

The absence of a detailed breakdown between suicide attempts and suicidal thinking, Dr Aursnes said, distorted the conclusions on the dangers of the drugs.

Using the information from the original trial Dr Aursnes and colleagues found that in 16 trials there were seven attempted suicides among people taking Seroxat, compared to one among those given a placebo.

The data, they write, when added to the information from trials of the other drugs of the class, "strongly suggests that the use of SSRIs are connected with increasing intensity per year of suicidal attempts". They make "a strong case for a conclusion, at least with a short time perspective, of an increased risk of suicidal attempts in adults taking antidepressants".

Dr Aursnes obtained the original trial results from the Norwegian regulatory authority, he said. When the MHRA asked for data on suicides from GlaxoSmithKline, what they received "was not the original science".

The drugs company, he said, provided a summary which added together suicide attempts and reports of patients feeling suicidal.

"I think the UK investigation could have been even more thoroughly done if they had looked through the primary data," he said.

He had attempted to alert the MHRA to his findings, he said. "I have tried but they have not shown any interest."

Dr Aursnes embarked on further analysis after studies in the British Medical Journal in February appeared to give the drugs a clean bill of health in adults. The authors found there was an increased frequency of suicide attempts by people on the drugs, but that it was not statistically significant. Their data came from the MHRA inquiry and did not include full GlaxoSmithKline figures.

GlaxoSmithKline said all its own extensive research into the safety of Seroxat - known also by the generic name paroxetine - confirmed its safety. "We take the safety of all our medicines extremely seriously and will, of course, review this study carefully when it becomes available," said a spokesman. "We can say these conclusions in no way reflect the picture ... about the benefits and risks of paroxetine in adults through an extensive clinical trials programme involving 24,000 patients or through the use of this medicine." (...)

I strid med pillegigant
dn.no 25.8.2005
Blir presset: Fire norske forskere sier legemiddelgiganten GlaxoSmithKline tar i bruk alle metoder for å stanse dem. Nye funn: De har publisert forskning som viser at bruk av lykkepillen Seroxat øker faren for selvmordsforsøk.
- De er helt fortvilte. Glaxo bruker alle midler, men klarer fortsatt ikke motbevise funnene våre, sier professor i farmakologi Ivar Aursnes ved Universitetet i Oslo (UiO).

GlaxoSmithKline sendte mandag ut en pressemelding hvor selskapet skarpt tilbakeviste funnene til de norske forskerne. Også GlaxoSmithKlines administrerende direktør, Åge Nærdal, avviser forskningsfunnene til firkløveret på UiO (se egen undersak.)

Bakgrunnen for feiden er et forskningsarbeid Aursnes ledet, som nylig ble publisert i det britiske tidsskriftet BMC Medicine.

Her dokumenterer fire norske forskere hvordan bruken av Seroxat øker faren for selvmordsforsøk. Nå opplever de hvordan det er å legge seg ut med en internasjonal legemiddelgigant.

De norske forskerne mener at GlaxoSmithKline (GSK) gjør sitt beste for å tåkelegge og fortie funnene deres. Samtidig unnlater GSK å redegjøre presist for hvordan det arbeidet da Seroxat kom på markedet for rundt 15 år siden.

70 mrd. i overskudd
GSK har hatt stor suksess med salg av Seroxat, som er bedre kjent som lykkepillen. Totalt hadde firmaet ifølge NRK et internasjonalt overskudd på 70 milliarder kroner i 2004.

Nå handler det om fortsatt distribusjon og salg av et av verdens mest solgte legemidler - Seroxat - på grunn av forskning gjort ved Universitetet i Oslo.

Dette har vakt stor internasjonal oppsikt, og er behørig omtalt i anerkjente britiske aviser som Financial Times og The Times.

I Storbritannia, hvor det årlig skrives ut rundt 2,4 millioner resepter av legemiddelet, styrkes nå kravet om at legemiddelet fjernes fra markedet. BBC varsler på sitt nettsted at tv-kanalen 22. oktober vil komme med nye avsløringer omkring Seroxat i programmet «Panorama».

Forskerne fant nemlig ut at middelet paroxetine - som er en viktig bestanddel i Seroxat - øker faren for selvmordsforsøk. 1500 personer var med i datamaterialet, og av disse var det syv selvmordsforsøk blant lykkepillebrukerne. Blant pasientene som fikk placebo - narrepiller - var det til sammenligning bare ett selvmordsforsøk.

- Tallene er alarmerende, sier matematikkprofessor Bent Natvig.

Triksing?
Han påpeker at forskerne har brukt nøyaktig det samme datamaterialet som Glaxo i sin tid brukte for å få Seroxat godkjent som lykkepille.

De norske forskerne går derfor langt i å antyde at Glaxo trikset med det vitenskapelige grunnlaget for å få Seroxat på markedet.

- Mye tyder på at de har fortolket dataene i sin favør, men dette kan vi ikke bevise. Alt tyder uansett på at Glaxo har gjort en svært dårlig jobb, sier Ivar Aursnes.

- Hva blir konsekvensene av dette?

- Det har vært skreket opp om dette gjentatte ganger. Myndighetene fant for en stund siden ut at Seroxat ikke var heldig for barn og unge på grunn av selvmordsrisiko. Nå har vi funnet ut at det også gjelder for voksne mennesker. Vi vil ikke nødvendigvis at produktet skal fjernes fra markedet, men mener at folk må få vite om bivirkningene, sier Aursnes.

Bent Natvig mener at Glaxo nå må tilbakevise at bruk av Seroxat ikke øker selvmordsrisikoen.

- Vår forskning taler for seg selv, så bevisbyrden ligger hos Glaxo. Vi kan bare vente og se om de greier å komme opp med presise opplysninger som dokumenterer at vi tar feil. Foreløpig har de ikke klart å komme opp med noe særlig imponerende, sier Natvig.

Bevisbyrden
Forskerne hevder det er tydelig at GSK nå føler seg presset, men sier det ikke bekymrer dem.

- Legemiddelindustrien opptrer akkurat som forventet. Det sier seg selv at de reagerer når penger for 2,4 millioner resepter er involvert, sier Ingunn F. Tvete.

Bent Natvig sier han forventer at GSK vil forlange store mengder dokumentasjon før de gir seg.

- Bevisbyrden burde være deres, men vi er selvfølgelig innforstått med hvordan bransjen opererer. Argumentasjonen om at vi har drevet datafisking holder rett og slett ikke mål. Vi har drevet etter korrekte vitenskapelige prosedyrer, sier Natvig, og får støtte av Aursnes.

- For vår del er arbeidet unnagjort, og det har liten hensikt for oss å gå i debatt med Glaxo. Men spørsmålet nå er hva britiske legemiddelmyndigheter foretar seg, sier Aursnes. (...)

STADIG FLERE VIL HA LYKKEPILLER
vg.no 13.2.1996
(...) Psykiatere forteller oss at det har vært et enormt behov for et produkt som ikke var farlig, og som ikke gir alvorlige bivirkninger (...)

Jeg tror pillen kalles ”lykkepille” fordi pasientene som bruker den er så glade for å bli kvitt depresjonene sine (Administrerende direktør Bente-Lill B. Romøren i Novo Nordisk Pharma AS.) (...)

Anklager om fusk med Novo-forskning
dr.dk 5.5.2006
En norsk professor beskylder Novo Nordisk for at have skjult oplysninger om selvmordsforsøg i forbindelse med depressionspillen Seroxat.

Det kommer frem i programmet "Den Mørke Side", der sendes lørdag på P1. Programmet er lavet i samarbejde med Forbrugerrådets blad Tænk, skriver Politiken.

Professor i farmakologi, Ivar Aursnes, har forsket i det materiale, som Novo Nordisk i 1990 sendte til myndighederne for at få godkendt Seroxat.

Aursnes anklager Novo Nordisk for i materialet bevidst at have forsøgt at skjule data om flere selvmordsforsøg i den gruppe, som tog Seroxat. (...)

Evelyn Pringle: Drip Drip - Paxil Info Leaks Out (Evelyn Pringle: Drypp drypp - Seroxatinformasjon lekker ut)
scoop.co.nz 26.4.2006
Secrecy agreements in litigation hide information about defective products or a company’s negligence, and sometimes go so far as to prohibit the parties from discussing that there ever was a lawsuit. Such is the case with Paxil and as a result, unwitting patients continued to take the drug long after its dangers were known to GlaxoSmithKline.

Many lawsuits filed against Glaxo have been settled out of court, with confidential agreements that prevent the public from knowing about the harmful effects of the Paxil.

Previously sealed documents and internal company memos suppressed with protective orders, prove that Glaxo knew about the problems with Paxil before it received FDA approval, but continued to sell the drug for over a decade without warning consumers. (...)