How safe is Celebrex? (Hvor sikker er Celebrex?)
(boston.com 25.2.2007)

Label and Approval History (fda.gov) (Label (preparatomtale))

UB researchers find potentially dangerous side effect of popular drug Unlike Vioxx, an arthritis medication that was taken off the market in 2004 due to patients reporting cardiovascular side effects, Celebrex has never been pulled off pharmaceutical shelves. Celebrex is a product of Pfizer.

On average, over one million Celebrex prescriptions are filled each month, according to the Celebrex Web site. Unlike Vioxx, an arthritis medication that was taken off the market in 2004 due to patients reporting cardiovascular side effects, Celebrex has never been pulled off pharmaceutical shelves. Celebrex is a product of Pfizer. (spectrum.buffalo.edu 6.2.2008)

Vellykket legemiddellansering (Tidsskr Nor Lægeforen 2000; 120:)

Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler (BMJ 2009;338:b966 (9 March))

- Celebra (Celebrex) mer enn dobler risiko for hjerteslag

Non-steroidal anti-inflammatory drug use and risk of atrial fibrillation or flutter: population based case-control study (Bruk av ikkesteroide antiinflammatoriske legemidler og atrieflimmer eller atrieflutter: en kasus kontrollstudie)
BMJ 2011; 343:d3450 (4 July)
Objectives To examine the risk of atrial fibrillation or flutter associated with use of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclo-oxygenase (COX) 2 inhibitors. (...)

Conclusions Use of non-aspirin NSAIDs was associated with an increased risk of atrial fibrillation or flutter. Compared with non-users, the association was strongest for new users, with a 40-70% increase in relative risk (lowest for non-selective NSAIDs and highest for COX 2 inhibitors). Our study thus adds evidence that atrial fibrillation or flutter needs to be added to the cardiovascular risks to be considered when prescribing NSAIDs. (...)

We identified prescriptions for non-aspirin non-selective NSAIDs (ibuprofen, naproxen, ketoprofen, dexibuprofen, piroxicam, and tolfenamic acid), older COX 2 inhibitors (diclofenac, etodolac, nabumeton, and meloxicam), and newer COX 2 inhibitors (celecoxib, rofecoxib, valdecoxib, parecoxib, and etoricoxib).3 21 Because of overlapping COX 2 selectivity, we collapsed the groups of older and newer COX 2 inhibitors into one group.3 Associated ATC (Anatomical Therapeutic Chemical Classification System) codes are provided in the web appendix. (...)

(Anm: Hva er atrieflimmer og atrieflutter? (pasienthandboka.no).)

(Anm: Atrieflimmer og atrieflutter (nhi.no).)

(Anm: Uten obduksjoner begraver sykehusene feilene sine. (Without Autopsies, Hospitals Bury Their Mistakes) (…) Da Renee Royak-Schaler uventet kollapset og døde 22. mai beordret ingen obduksjon. (…) Diagnostiske feil, som studier viser er vanlig, forblir uoppdaget, og tillater at leger kan fortsette sin praksis på andre pasienter med en falsk følelse av trygghet. (…) Mulighetene for å lære om effektiviteten av medisinske behandlinger og progresjon av sykdommer går tapt. Unøyaktig informasjon ender opp i dødsattester, og undergraver påliteligheten for avgjørende helsestatistikk. (propublica.org 15.12.2011).)

(Anm: atrieflimmer; ujamn takt og styrke av puls og hjarteslag fordi hjarteslaga vert stimulerte av impulsar frå raske, uregelbundne flimrande trekkingar i forkammermuskulaturen; orda flimmer, flimmerpuls, hjarteflimmer viser oftast til denne tilstanden som kan gi lite plager, men stundom tung pust, hjartebank og ein tendens til emboliar frå venstre atrium (auricula) gjerne til hjernen; årsakene er mangslungne, f eks revmatisk hjartesjukdom, hjartesvikt av ulike typar, koronarsjukdom, tyreotoksikose, alkohol, perikarditt, anomaliar i impulsleiinga, ofte er tilstanden idiopatisk – lone fibrillation, i sjeldne tilfelle arveleg pga mutasjon i eit gen på kromosom 10; jf ventrikkelflimmer EN atrial fibrillation Kilde: Norsk medisinsk ordbok.)

(Anm: RBK-talent har fått sjelden betennelse i hjertet. 19-åringen har fått påvist betennelse på hjerteposen, eller perikarditt som det heter. Ifølge RBK.no er stortalentet ikke innlagt ved St. Olavs Hospital, men han er under behandling og får oppfølging ved hjerteklinikken på sykehuset. (adressa.no 27.2.2017).)

(Anm: Hjerteposebetennelse – perikarditt. (…) Hvordan stilles diagnosen? Legen får mistanke om diagnosen ut fra sykehistorien. Det mest typiske funnet er en gnidningslyd som høres med stetoskopet. Den skyldes at de to hinnene i perikardiet er blitt betente og gnisser mot hverandre. Hvis det samler seg mer væske i hjertesekken, som det noen ganger gjør, kan gnidningslyden forsvinne. (nhi.no 27.2.2017).)

(Anm: Diklofenak og hjerteinfarkt (legemiddelverket.no 13.9.2006).)

(Anm: Diclofenac; fornorsket: diklofenak; markedsføres under handelsnavn som bl.a. Voltaren, Voltarol, Diclon, Diclodan, Dicloflex, Difen og Cataflam (pdr.net).)

(Anm: Vanlige smertestillende legemidler linket til en høyere risiko for hjerteproblemer. Common Pain Meds Are Linked to a Higher Risk of Heart Problems. Ibuprofen and other common painkillers are linked to an increased risk of cardiac arrest, according to a new Danish study published in the European Heart Journal—Cardiovascular Pharmacotherapy. The authors say these drugs should be used with caution and that people with heart problems may want to avoid them. (time.com 15.3.2017).)

(Anm: Diklofenak og ibuprofen er assosiert med øket risiko for hjertestans. Diclofenac and ibuprofen are associated with increased risk of cardiac arrest. Use of the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac and ibuprofen are associated with a significantly increased risk of cardiac arrest, a large Danish study has found. The authors of the study, which was reported in the European Heart Journal: Cardiovascular Pharmacotherapy,1 said that the findings were a stark reminder that NSAIDs were not harmless and should only be used after consulting a healthcare professional. BMJ 2017;356:j1358 (Published 16 March 2017).)

(Anm: Medisiner hjelper lite mot ryggsmerter. En ny studie viser at medisiner som Ibux og Voltaren ikke hjelper noe særlig mot akutte ryggsmerter. Eksperter mener det bør forskes mer på andre behandlingsmetoder. (nrk.no 4.2.2017).)

(Anm: Forskningschef: Gigtmidlet diclofenac bør ikke bruges. Hjerteforeningens forskningschef Gunnar Gislason mener, at der for hjertepatienter er høj risiko ved brugen af gigtmidlet diclofenac, og den modsvarer ikke effekten. (hjerteforeningen.dk 17.3.2016).)

(Anm: Diclofenac tablets now only available as a prescription medicine (medicalnewstoday.com 14.1.2015).)

Pfizer's Celebrex arthritis drug adds heart warning (Pfizers artrittlegemiddel Celebrex tilføyes hjerteadvarsler)
USA TODAY 1.8.2005
NEW YORK (Reuters) — Pfizer (PFE) sa mandag at preparatomtalen for artrittlegemidlet Celebrex er blitt endret med tilføyelse av en markant advarsel om mulig kardiovaskulær risiko, slik som økt risiko for hjerteanfall, på linje med nye advarsler for andre artritt og smertestillende legemidler. (Pfizer (PFE) said Monday that the label of its Celebrex arthritis drug has been changed to add a prominent warning of possible cardiovascular risks, such as increased risk of heart attacks, in line with new warnings of other arthritis and pain drugs.)

Pfizer anfører i pakningsvedlegget for legemidlet — et av firmaets største produkter, hvor det nylig har vært en markert nedgang i salget pga. bekymringer angående sikkerhet — at de anbefaler midlet forskrevet "i laveste effektive dose for kortest mulig tid." (...) (Pfizer said the package insert label of the drug — one of the company's biggest products, sales of which have recently declined sharply because of safety concerns — recommends it be prescribed "at the lowest effective dose for the shortest duration.")

En statlig rådgivende legegruppe sa i februar at Celebrex "signifikant" økte risikoen for hjerteproblemer og slag. Men rådgiverne til Food and Drug Administration anbefalte at det ble værende på markedet pga. sin nytte for artrittpasienter. (A federal advisory panel of doctors in February said Celebrex "significantly" raised the risk of heart problems and strokes. But the advisers to the Food and Drug Administration recommended it remain on the market because of its benefits to arthritis patients.)

(Anm: Substansen celecoxib (celekoksib i Norge) markedsføres under handelsnavnet Celebra i Norge, Celebrex i Danmark, Sverige, USA osv.)

Celebrex raises heart attack risk –study
cnn.com 28.2.006
Pfizer's commonly used painkiller and arthritis treatment more than doubles heart attack likelihood, says a new study.

LONDON (Reuters) - Celebrex, a commonly used painkiller and treatment for arthritis, doubles the risk of a heart attack, researchers said on Wednesday.
Professor Richard Beasley, of New Zealand's Medical Research Institute in Wellington, said analysis of trials of the Pfizer (Research) drug, also known as celecoxib, showed the raised odds of a heart attack were common to the entire class of drugs known as COX-2 inhibitors.

Merck (Research) pulled its drug Vioxx from the market in 2004 after a study showed it doubled the risk of a stroke or heart attack in people taking it for at least 18 months.

"Our evidence shows an increased risk of heart attack in patients taking celecoxib," said Beasley.

"Drug regulatory authorities need to urgently re-examine the assessment of the drug in light of these findings," he added in a statement.
An American woman is suing Pfizer in a court case set to be heard in June in Alabama. She alleges that Celebrex, which she was taking for back pain, caused a stroke she suffered in 2005.

Pfizer, in response to the analysis, said the drug had been studied in more than 40 controlled trials that included more than 44,000 patients including approximately 25,000 who took Celebrex.

"There are more comprehensive meta-analyses on the cardiovascular safety profile of Celebrex which are published in peer-reviewed journals," a company spokesman said.

COX-2 inhibitors were designed as a safer long-term alternative to older painkillers, known as non steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen and naproxen, which can cause stomach damage.
The drugs work by blocking selectively a protein called COX-2 that has been linked to inflammation.

Last year the European Union restricted the use of COX-2 pain relievers saying they should not be given to people with ischaemic heart disease or stroke. It also suggested the lowest dose and shortest course of the drug should be prescribed.

Beasley and his team looked at four trials involving 4,422 patients which compared Celebrex to a placebo. The study, published in the Journal of the Royal Society of Medicine, showed the drug was associated with a 2.26 fold increased risk of a heart attack.

In six other studies, patients taking the drug had a 1.88 fold raised risk of a heart attack compared to patients taking older painkillers such as ibuprofen and paracetamol.

"Given the popularity of celecoxib in the treatment of arthritis, drug regulators must undertake an up-to-date risk assessment based on the findings presented here," said Beasley. (...)

- It is an extremely dangerous drug...

Pain drug too deadly, group says
usatoday.com 28.2.2006
Citing more than 2,000 deaths over two decades, a consumer group called Tuesday for the Food and Drug Administration to ban the prescribed pain reliever commonly sold as Darvon or Darvocet.

Washington-based Public Citizen, which previously called for bans on Vioxx and other drugs eventually taken off the market, says that the United States should follow the lead set by the British government, which last year began withdrawing the drug from that health system.

Both the British government in correspondence to doctors, and Public Citizen in its petition to the FDA, say the drug provides poor pain relief at significant risk.

"It is an extremely dangerous drug, and it's just reckless for any company to be selling it, and it's reckless in the extreme for the FDA to allow this to stay on the market," says Sidney Wolfe, director of Public Citizen's Health Research Group. (...)

- Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler

Doctor Pleads Guilty to Research Fraud Involving Vioxx and Celebrex (Lege erklærer seg skyldig i forskningssvindel som involverer Vioxx og Celebrex)
pharmpro.com (23.2.2010)
BOSTON (AP) — A doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex pleaded guilty Monday to one count of federal health care fraud.

An attorney for Dr. Scott Reuben said the anesthesiologist will have to repay $361,932 in research grants and forfeit assets worth at least $50,000 as penalty for his conduct following a plea hearing in U.S. District Court. (...)

Massachusetts Doctor Accused of Fraud by Faking Research (Lege fra Massachusetts anklaget for svindel ved å forfalske forskning)
pharmpro.com 15.1.2010
BOSTON (AP) — Federal prosecutors announced Thursday that they have filed a health care fraud charge against a doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex.

Court documents indicate that Dr. Scott Reuben, an anesthesiologist, has agreed to plead guilty in exchange for prosecutors recommending a more lenient sentence of up to 10 years imprisonment, a $250,000 fine and forfeiture of assets worth at least $50,000 that Reuben received for the research.

Prosecutors allege the former chief of acute pain at Baystate Medical Center in Springfield sought and received research grants from pharmaceutical companies but never performed the studies. He fabricated patient data and submitted information to anesthesiology journals that unwittingly published it, court documents allege.

Reuben, a Longmeadow resident, took leave after the hospital said last year that a routine review found that some of his research was not approved by an internal hospital review board. Further investigation found 21 papers published in anesthesiology journals between 1996 and 2008 in which Reuben made up some or all data, the hospital said. Hospital officials said Reuben did not admit to the fabrications. (...)

Juks med studier av postoperative smerter
Tidsskr Nor Legeforen 2009; 129:1658-9 (27.8.2009)
En kjent internasjonal forsker har måttet trekke tilbake 21 av sine mye siterte artikler om medikamentell profylakse og behandling av postoperativ smerte. Hvilken betydning har dette for forskning og klinisk praksis? (...)

US researcher fabricated pain studies (Amerikansk forsker fabrikkerte smertestudier)
pharmatimes.com 12.3.2009
One of the largest cases of academic fraud has come to light after it was revealed that a researcher in the USA fabricated data in at least 21 studies on pain drugs.

The work of Scott Reuben, an anaesthesiologist at Baystate Medical Center in Massachusetts, has been the subject of an investigation since May last year. It now appears that he never conducted the clinical trials that he wrote about in journals.

Specifically, Dr Reuben’s ‘research’ had promoted the notion of shifting from nonsteroidal anti-inflammatory drugs (NSAIDs) to the newer COX-2 inhibitors, such as Merck & Co’s Vioxx (rofecoxib) and Pfizer’s Celebrex (celecoxib), and Bextra (valdecoxib). He had argued that using these drugs in combination with Pfizer’s Neurontin (gabapentin) and Lyrica (pregabalin) could be effective in decreasing postoperative pain and reduce the use of addictive painkillers during recovery. (...)

(Anm: Massachusetts Doctor Accused of Fraud by Faking Research (pharmpro.com 15.1.2010).)

- Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler.

Prominent celecoxib researcher admits fabricating data in 21 articles (Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler)
BMJ 2009;338:b966 (9 March)
A well known researcher who promoted the use of the non-steroidal anti-inflammatory drug celecoxib has admitted fabricating data in 21 of his 72 articles indexed by PubMed. The case is "among the biggest which has come to light," said Harvey Marcovitch, chairman of the Committee on Publication Ethics, an international forum for publishers and editors of peer reviewed journals.
Scott S Reuben, chief of the acute pain service at Baystate Medical Center in Springfield, Massachusetts, has admitted the fraud, says a notice issued by the centre in late January. (...)

Dr Reuben, who received research grants from Pfizer, the US manufacturer of celecoxib (marketed as Celebrex), and served on its speakers’ bureau, pioneered "multimodal analgesia," the combination of celecoxib with another Pfizer drug, the anticonvulsant pregabalin (Lyrica). The combination, Dr Reuben claimed, was preferable to opioids, and it became a mainstay in pain management.

James Eisenach, editor in chief of Anesthesiology, said that Dr Reuben’s research was central to the claim that celecoxib reduces pain at six and 12 months after surgery. He said that the fraud creates a "hole" in pain research and casts doubt on claims about celecoxib.
Dr Eisenach says in an editorial to be published in the May 2009 issue of Anesthesiology (http://pdfs.journals.lww.com/anesthesiology/9000/00000/99939.pdf) that the retracted articles "have been considerably cited since 2002" and that mere retraction of the articles will not be enough. He says that the journal will use its peer review system "to assure that these articles are no longer cited by our authors." He also calls for "submission of studies reexamining the questions that seemed to be answered by Reuben in the retracted studies." (...)

- Når det gjelder innrapporteringer av symptomer, vet ikke pasienter best?

In Reporting Symptoms, Don’t Patients Know Best? (Når det gjelder innrapporteringer av symptomer, vet ikke pasienter best?)
nytimes.com 12.4.2010
For omtrent seks år siden fikk jeg noen prøver av et legemiddel av legen min for behandling av smerter grunnet en skade. Jeg tok det i noen dager og våknet en morgen opp med en stor rød blodblemme (blister) på tungen min. Jeg hadde tidligere aldri opplevd noe slikt, og undret på om det kunne skyldes pillene. De hjalp uansett ikke mye så jeg sluttet å ta dem. Blodblemmen forsvant. Jeg nevnte dette neste gang jeg så legen, men han sa at det må ha vært en tilfeldighet. (About six years ago, my doctor gave me some samples of a drug to treat pain from an injury. I took it for a few days and then woke up one morning with a big red blister on my tongue. I’d never had anything like it before, and I wondered if the pills might be to blame. They weren’t helping much anyway, so I quit taking them. The blister went away. I mentioned it the next time I saw the doctor, but he said it must have been a coincidence.)

Ikke lenge etter dette ble legemidlet Bextra trukket fra markedet i USA. Det hadde blitt linket til hjerteinfarkt og en farlig tilstand som kalles Stevens-Johnson syndrome — som kan forårsake munnblemmer (blisters) blant flere ting. (...) (Not long after, the drug, Bextra, was taken off the market in the United States. It had been linked to heart attacks and also to a dangerous condition called Stevens-Johnson syndrome — which can cause mouth blisters, among other things. )

(Anm: Stevens-Johnson syndrome (mayoclinic.org 22.4.2014).)

(Anm: Blisters (blodblemmer) - Paroxetine (Oral Route) (mayoclinic.org 1.12.2014).)

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

(Anm: Celebra (Celebrex; celecoxib) (mintankesmie.no).)

(Anm: Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler. Prominent celecoxib researcher admits fabricating data in 21 articles. BMJ 2009;338:b966 (9 March).)

(Anm: Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor. Valdecoxib was manufactured and marketed under the brand name Bextra by G. D. Searle & Company as an anti-inflammatory arthritis drug.[1] (en.wikipedia.org).)

(Anm: Tannleger og tannhelse (munnhulen er kroppens speil). (mintankesmie.no/).)

(Anm: Tannleger og tannhelse (munnhulen er kroppens speil). (mintankesmie.no/).)

(Anm: Astmaspray kan gi munnsopp. (…) Noen er mer plaget av dette enn andre, men du merker det ved at det svir, blir ømt, du blir rød, får sår i munnen og et hvitt belegg på tungen, opplyser Grethe Amdal, seniorrådgiver i Norges Astma- og Allergiforbund (NAAF) til NRK.no. (…) Har du en kraftig immunsvikt som hiv/aids, vil dette spre seg nedover i spiserøret, hvilket er meget ubehagelig, fortsetter han. (…) Munnen avslører sykdom. (…) Han oppfordrer til å oppsøke tannlegen hvis du har sår i munnhulen som ikke går bort. Det kan være ufarlige hudsykdommer, men også noe mer alvorlig, som kreft.) (nrk.no 13.5.2011).)

- Pfizer forliker Celebrex-søksmål

Pfizer fails to end lawsuit over Bextra, Celebrex safety
reuters.com 28.3.2013
(Reuters) - Pfizer Inc has failed to persuade a federal judge to dismiss a shareholder lawsuit accusing the company of fraudulently misrepresenting the safety of its Celebrex and Bextra pain-relieving drugs.

While dismissing some of the claims, U.S. District Judge Laura Taylor Swain in Manhattan said a reasonable jury could find that Pfizer and several top executives intended to mislead shareholders about the drugs' cardiovascular risks.

"The record is replete with evidence that defendants recognized that Celebrex and Bextra had associated cardiovascular risks, that such risks would be considered material by investors, and that defendants nonetheless misrepresented and actively concealed these risks," she wrote. (...)

(Anm: Lawsuit vs Pfizer over Celebrex, Bextra safety is revived. April 12 (Reuters) - A federal appeals court on Tuesday revived a long-running class-action lawsuit accusing Pfizer Inc of misleading shareholders about the safety of its Celebrex and Bextra pain-relieving drugs. The 2nd U.S. Circuit Court of Appeals in Manhattan said a lower court judge erred in excluding testimony by Daniel Fischel, a former University of Chicago Law School dean hired as an expert by the shareholders to assess potential damages. (finance.yahoo.com 12.4.2016).)

Retssag koster medicinalkoncern knap 1 mia. kr.
medwatch.dk 10.10.2012
En af verdens største medicinalselskaber indgik fredag forlig med sine aktionærer i sagen om, hvorvidt virksomheden havde fortegnet resultaterne fra et klinisk forsøg af gigtlægemiddel.

Retten i New Jersey stod fredag for et forlig mellem Pfizer og firmaets aktionærer, der kollektivt havde sagsøgt medicinalvirksomheden for at fordreje sandheden om kliniske forsøg lavet på gigtmedicinen Celebrex.

Det kostede virksomheden 164 mio. dollar, eller 950 mio. kroner, skriver Reuters.

Forliget kom bare to uger, inden parterne skulle i retten, og trods det nægter Pfizer stadig at skulle have gjort noget forkert, sagde en talsmand ifølge Reuters efter forliget.

Har kørt siden 2003
I 2002 overtog Pfizer virksomheden Pharmacia Corporation, som fremstillede gigtmedicinen Celebrex. Et lægemiddel, der i dag indtager femtepladsen for bedst sælgende hos virksomheden og omsætter for omkring 2,5 mia. dollars om året. (...)

Efterfølgende har sagen bølget frem og tilbage med både appeller og forsøg på at få sagen afvist, hvilket dog ikke lykkedes. Retssagen skulle have startet d. 22. oktober. (...)

Pfizer Settles Celebrex Lawsuit (Pfizer forliker Celebrex-søksmål)
pharmatimes.com 2.5.2012
Pfizer Inc. has settled a lawsuit filed by Brigham Young University over development of the blockbuster painkiller Celebrex for $450 million, according to a regulatory filing. Terms of the settlement weren't disclosed in an announcement by the drug company and the Mormon Church-owned school in Utah. However, Pfizer said in a regulatory filing with the U.S. Securities and Exchange Commission that it was taking a $450 million charge against first-quarter earnings to settle the case.

BYU and Pfizer battled for six years over the discovery of an enzyme that led to the development of Celebrex, a breakthrough in the treatment of arthritis and inflammation. A jury trial had been set to start May 29 in U.S. District Court in Salt Lake City. BYU had sought a 15 percent royalty on sales of Celebrex, or about $9.7 billion. The university also could have sought billions of dollars more in punitive damages and interest.

BYU's lawsuit said a chemistry professor, Daniel Simmons, discovered the genetic workings of the drug in the early 1990s. It accused Pfizer of violating a research agreement the school made with predecessor companies. As part of the settlement, BYU plans to endow a Dan Simmons Chair in recognition of his lifelong work advancing human health. (...)

Diverse artikler

Pfizer Finalizes $60M Settlement With States Over Off-Label Marketing of COX-2 Inhibitors
kaisernetwork.org 23.10.2008
Pfizer on Wednesday said it will pay $60 million to 33 states and Washington, D.C., to settle lawsuits that claimed the company promoted the COX-2 inhibitors Bextra and Celebrex for unapproved uses, the Miami Herald reports. The agreement is part of an $894 million settlement that the company announced last week to cover more than 90% of pending lawsuits involving the drugs. The settlement also includes $745 million to settle personal injury claims and $89 million for consumer fraud claims brought by insurers and consumers seeking to recoup money spent on the drugs.

COX-2 inhibitors drew increased scrutiny when Merck in 2004 withdrew its COX-2 inhibitor Vioxx from the market because of a link to cardiovascular risks. Celebrex is the only remaining COX-2 inhibitor on the market. (...)

Pfizer settles Celebrex and Bextra lawsuits
pharmatimes.com 17.10.2008
Drug giant Pfizer has reached an $894 million agreement to resolve almost all of the lawsuits regarding its pain drugs Bextra (valdecoxib) and Celebrex (celecoxib).

The drugmaker has been embroiled in numerous court battles with patients claiming to have suffered cardiovascular events after taking COX-2 inhibitors Bextra, which was withdrawn from the US market in 2005 on safety grounds, and Celebrex.

The announcement follows favourable rulings which saw federal and New York court judges decide that a majority of the personal injury cases failed to present reliable scientific evidence to prove Celebrex can cause heart attacks or strokes at its most commonly prescribed dose. (...)

Celebrex risky in high-risk patients, study finds
reuters.com 1.4.2008
CHICAGO (Reuters) - Doctors should prescribe the lowest doses of Celebrex possible in patients at high risk of heart problems, researchers who did a combined analysis of six studies of the Pfizer Inc pain drug said on Monday. (...)

Doctors should exercise caution in prescribing the drug, generally known as celecoxib, in high-risk patients, said Solomon, whose analysis was also published online in the journal Circulation. (...)

Ahead of the Bell: Celebrex Review
forbes.com 25.3.2008
(...) FDA will present safety data on Pfizer's Celebrex, which was approved in 2006 to treat rheumatoid arthritis in children.

According to documents released ahead of the meeting, FDA has received 10 reports of adverse reactions with Celebrex among children, including two deaths. FDA scientists concluded the cases "did not reveal any notable unexpected safety concerns," with Celebrex. (...)

UB researchers find potentially dangerous side effect of popular drug
spectrum.buffalo.edu 6.2.2008
UB researchers have found that Celebrex, a popular drug that relieves the pain and stiffness associated with osteoarthritis and rheumatoid arthritis, can induce irregular heartbeat rhythms.

On average, over one million Celebrex prescriptions are filled each month, according to the Celebrex Web site. Unlike Vioxx, an arthritis medication that was taken off the market in 2004 due to patients reporting cardiovascular side effects, Celebrex has never been pulled off pharmaceutical shelves. Celebrex is a product of Pfizer. (...)

Celebrex disrupts heart rhythm in fruit flies
reutershealth.com 25.1.2008
CHICAGO (Reuters) - Celebrex, an arthritis drug in the same class as the recalled painkiller Vioxx, caused irregular heartbeats in fruit flies and in heart cells taken from laboratory rats, U.S. researchers said on Friday.

"When we tried this drug on the fly heart it became clear that it gave rise to very pronounced arrhythmia," said Dr. Satpal Singh, a pharmacologist at the State University of New York at Buffalo. (...)

Celebrex Ads To Return
forbes.com 2.4.2007
Confronting the drug safety debate head-on, Pfizer will advertise its pain pill Celebrex to consumers for the first time in two years. (...)

Heart Experts Issue Guidelines on Use of Celebrex
healthfinder.gov 26.2.2007
Cox-2 painkiller should be last resort because of cardiovascular risk, American Heart Association says

MONDAY, Feb. 26 (HealthDay News) -- The American Heart Association is weighing in on the potential heart dangers of controversial cox-2 nonsteroidal anti-inflammatory drug (NSAID) painkillers such as Celebrex.

In a statement published Monday in Circulation, the association says these painkillers -- which include two other drugs, Vioxx and Bextra, now withdrawn from the market -- do increase the risk of heart attack and stroke, and doctors need to change the way they prescribe these pain relievers to people with, or at risk for, heart disease. Cox-2 pain relievers are so named because they specifically target the cox-2 enzyme.

However, other, less targeted or "selective" non-cox-2 NSAIDs may also increase the risk, the AHA said. (...)

(Anm: NSAID Use Is Associated with Elevated Risk for Bleeding in Patients with Atrial Fibrillation Receiving Antithrombotic Therapy Ann Intern Med 2014 Nov 18; 161:690.)

(Anm: Värktabletter kopplas till hjärtproblem. Det finns ett samband mellan en högre risk för hjärtsvikt och medicinering med värktabletter som Voltaren, Ipren och Magnecyl, enligt en ny stor studie. Studien som publicerats i British Medical Journal visar att personer, som inom de senaste 14 dagarna tagit så kallade NSAID-läkemedel, har en 19 procent högre risk för att tas in på sjukhus för hjärtsvikt, jämfört med personer som tagit tabletterna längre tillbaka i tiden. (dagensmedicin.se 30.9.2016).)

(Anm: Mange NSAID knyttet til hjertefeil. Many NSAIDs Associated With HF. 'A clear risk to some... and tighter regulation is justified'. (…) For the individual drugs, odds ratios ranged from 1.16 (95% CI 1.07-1.27) for naproxen to 1.83 (95% CI 1.66-2.02) for ketorolac, and were significant for the following: Diclofenac – Ibuprofen – Indomethacin – Ketorolac – Naproxen – Nimesulide – Piroxicam – Etoricoxib - Rofecoxib (medpagetoday.com 29.9.2016).)

(Anm: NSAID; non-steroidal anti-inflammatory drugs; Ikkesteroide antiinflammatoriske midler (no.wikipedia.org).)

(Anm: «Ufarlige» smertestillende knyttet til økt risiko for hjertestans. 'Harmless' Painkillers Associated With Increased Risk of Cardiac Arrest. Painkillers considered harmless by the general public are associated with increased risk of cardiac arrest, according to research published in the March issue of European Heart Journal - Cardiovascular Pharmacotherapy.1 Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used drugs worldwide and some, including ibuprofen, are available over the counter. (pharmpro.com 16.3.2017).)

(Anm: Combination of NSAIDs and gastric protection can lead to inflammation in small intestine. Patients with inflammatory diseases are often prescribed non-steroidal anti-inflammatory drugs. They are also often recommended to use a proton pump inhibitor to protect their stomach. (news-medical.net 11 .4.2017).)

(Anm: Reseptfrie NSAID-er linkes til økt risiko for hjertestans, ifølge studie. Smertestillende legemidler som anses ufarlige for publikum er assosiert med økt risiko for hjertestans, ifølge forskning publisert i dagens utgave av European Heart Journal - Cardiovascular Pharmacotherapy. (…) Disse inkluderte de ikke-selektive NSAID-er (diclofenac, naproxen, ibuprofen) og COX-2-hemmere (rofecoxib celekoksib). Over-the-counter NSAIDs linked to elevated risk of cardiac arrest, study finds. Painkillers considered harmless by the general public are associated with increased risk of cardiac arrest, according to research published today in the March issue of European Heart Journal - Cardiovascular Pharmacotherapy. (…) These included the non-selective NSAIDs (diclofenac, naproxen, ibuprofen), and COX-2 selective inhibitors (rofecoxib, celecoxib). (news-medical.net 15.3.2017).

(Anm: Ibuprofen er knyttet til 31 % økning i risiko for hjertestans. Ibuprofen linked to 31% increase in risk of cardiac arrest. A study emerging from Denmark has found that the use of over-the-counter pain killer, Ibuprofen, is associated with an increased risk of cardiac arrest. In particular, the research warned against the view of nonsteroidal anti-inflammatory drugs (NSAID) as without risk and advised against people using the pain killers who had pre-existing cardiovascular problems. (…) Of those who were taking NSAIDs, the use of ibuprofen was associated with a 31% increase in the risk of cardiac arrest. As well as this, patients taking diclofenac, another NSAID – only available by prescription in the USA and the UK, were found to have a 50% increase in the risk of cardiac arrest. (pharmatimes.com 16.3.2017).)

(Anm: Kardiovaskulære risici ved behandling med nonsteroide antiinflammatoriske lægemidler (NSAID). KONKLUSION NSAID-behandling er associeret med en lang række kardiale komplikationer i form af destabilisering af blodtryksbehandling, hjertesvigt, myokardieinfarkt, atrieflimren, venøs tromboemboli, blødning ved kombinationsbehandling med antitrombotika og pludselig hjertedød. Selv korttidsbehandling synes at være associeret med en øget risiko, og særligt diclofenac har en uheldig risikoprofil. Dertil kommer, at der er en dosisrelateret øgning i de kardiovaskulære risici forbundet med NSAID-behandling, hvorimod den terapeutiske og smertestillende effekt ikke øges tilsvarende. NSAID-behandling frarådes derfor til patienter med hjerte-kar-sygdom, og anvendelse af diclofenac frarådes generelt. Ugeskr Læger 2016;178:V08160612.)

(Anm: Using NSAIDs during a cold may increase heart attack risk. Taking ibuprofen or other nonsteroidal anti-inflammatory drugs to help relieve cold or flu symptoms may seem harmless, but new research suggests otherwise. It could increase the risk of heart attack. Study co-author Dr. Cheng-Chung Fang, of the National Taiwan University Hospital, and colleagues recently reported their findings in The Journal of Infectious Diseases. (medicalnewstoday.com 6.2.2017).)

(Anm: NSAIDs offer little benefit for spinal pain, review finds. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen offer little more clinical benefit to patients with spinal pain than a placebo, a systematic review and meta-analysis has found. The review of 35 randomised placebo controlled trials involving 6065 people, published in the Annals of the Rheumatic Diseases,1 found that NSAIDs did provide some relief from pain and disability but found little evidence that they were more effective than placebo. Researchers found that, in every six patients treated with an NSAID, only one would benefit. BMJ 2017;356:j605 (Published 06 February 2017).)

(Anm: Demente rammes i højere grad af hjerte-kar-sygdom. Hjerteforeningen følger ministerens arbejde med handlingsplan om demens, der er essentiel for hjertepatienter også. Demens og hjerte-kar-sygdomme har fælles risikofaktorer, siger forskningschef. (hjerteforeningen.dk 3.10.2016).)

(Anm: NSAID-preparat farligt efter hjärtinfarkt. Antiinflammatoriska läkemedel av NSAID-typen är farligt ihop med blodförtunnare efter hjärtinfarkt. (lakemedelsvarlden.se 25.2.2015).)

(Anm: Vanlige smertestillende «øker risiko for hjertesvikt". (Common painkillers 'increase heart failure risk' (…) The British Medical Journal study looked at 10 million people, aged 77 on average, who took the drugs. (…) 'Use with caution' The British Heart Foundation (BHF) said patients should be on the lowest dose possible of NSAIDs for the shortest possible time.) (bbc.com 29.9.2016).)

(Anm: Vanlige smertestillende knyttet til svak økning i risiko for hjerteinfarkt. Common Painkillers Tied to Slight Rise in Heart Attack Risk. TUESDAY, May 9, 2017 (HealthDay News) -- Commonly used painkillers such as Motrin, Advil and Aleve might increase your risk for heart attack, even in the first week of use, a new study suggests. Overall, these drugs and others known as nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of a heart attack by 20 to 50 percent, compared with not using them, researchers found. (medicinenet.com 9.5.2017).)

(Anm: Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study. (…) Conclusions The risk of hospital admission for heart failure associated with current use of NSAIDs appears to vary between individual NSAIDs, and this effect is dose dependent. This risk is associated with the use of a large number of individual NSAIDs reported by this study, which could help to inform both clinicians and health regulators. BMJ 2016;354:i4857 (Published 28 September 2016).)

(Anm: Gigtmedicin skal bruges med omtanke til hjertepatienter. (…) Læger, der udskriver gigtmedicin af typen NSAID (non-steroide anti-inflammatoriske lægemidler), bør være særligt opmærksomme på, at denne type medicin giver en øget risiko for hjertesygdomme hos patienter. Det drejer sig specifikt om produkterne Diclofenac, Ibuprofen og Naproxen. I produktresumeerne for de nævnte produkter, står det udførligt beskrevet, at disse midler er kontraindicerede ved svær hjerteinsufficiens. (laegemiddelstyrelsen.dk 17.3.2016).)

(Anm: Potential Hazards of Adding Nonsteroidal Anti-inflammatory Drugs to Antithrombotic Therapy After Myocardial Infarction. Time for More Than a Gut Check. JAMA. 2015;313(8):801-802. (February 24).)

How safe is Celebrex? (Hvor sikker er Celebrex?)
boston.com 25.2.2007
The FDA has thousands of accounts suggesting the painkiller may be linked to heart attacks. Critics are unsure if flaw is in drug or agency's reporting system. (...)

Dr. David Graham, an FDA drug safety reviewer initially prevented by the agency from publishing research pointing to Vioxx's heart problems, was deposed for Vioxx lawsuits -- over FDA objections. "There is no question in my mind" that drugs like Celebrex increase heart attack risk "from the first tablet," Graham said. (...)

(Anm: Celebrex (celecoxib; celekoksib); markedsføres under handelsnavnet Celebra i Norge).

Alabama judge sets trial in Celebrex lawsuit
al.com 27.2.2006
EUFAULA, Ala. (AP) — A judge set a June 6 trial date for a lawsuit filed by a woman who claims the arthritis medication Celebrex was to blame for a stroke she suffered last year.

Barring delays, plaintiff's attorneys said Monday the trial could be the nation's first over the popular pain medicine by Pfizer Inc., which projected more than $2 billion in sales for Celebrex this year.

Rosie Ware contends Celebrex was to blame for a stroke she suffered a year ago at age 53. She claims Pfizer and other companies understated the risks of the drug and failed to warn consumers of possible side effects.

An attorney for Ware, Jere Beasley of Montgomery, said about 450 lawsuits have been filed over Celebrex.

A Pfizer spokesman did not immediately return a phone call seeking comment. The drug's Web site includes a warning that Celebrex may increase the risk of stroke or heart attack in some people.

Celebrex is part of a class of drugs called cox-2 inhibitors. It is the only one of its type remaining on the market after Vioxx and Bextra were withdrawn because of evidence they could raise the risk of stroke or a heart attack.
Pfizer is funding a study to determine whether Celebrex leads to more heart problems than other pain relievers.

Studies: Celebrex May Stop Colon Cancer
abcnews.go.com 3.4.2006
Studies: Celebrex May Prevent Colon Cancer but Still Risky for Heart (...)

Vellykket legemiddellansering
Tidsskr Nor Lægeforen 2000; 120:
Det er grunn til å gratulere firmaene Pfizer og Pharmacia med en vellykket lansering av legemidlet Celebra. Spesielt er legemidlets fortreffeligheter gjort rede for i et større oppslag i avisen Dagbladet dagen før midlet var å finne i hyllene på norske apoteker (1). Kopi av avisoppslaget er sendt meg fra de nevnte firmaer for at jeg skal kunne svare på spørsmål fra eventuelle nysgjerrige pasienter. Kollega Olav Bjørnebo, som selv har en revmatoid lidelse, har ifølge oppslaget ”gode erfaringer” med medikamentet. Jeg har noen kommentarer til hans medvirkning til lanseringen.

Medikamentet er godkjent til bruk på pasienter med revmatoid artritt og artrose. Bjørnebo er imidlertid sitert på følgende: ”Celebra er et framskritt og kan brukes på alle (min uthevning) betennelsestilstander i muskel-skjelettsystemet.” Er dette korrekt? (...)

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