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Falsk informasjon

- Produsenten av OxyContin villedet om risiko for avhengighet (OxyContin maker misled on addiction risks) (msnbc.msn.com 10.5.2007)

- Det er ingen grunn til å frykte tilsynsmyndigheten når du som lege forskriver vanedannende legemidler for å gi pasienten en effektiv behandling, sier avdelingsdirektør Jørgen Holmboe i Statens helsetilsyn. (kundeweb.aggressive.no)

Fire milliarder i "heroin"-bot
(e24.no 13.5.2007)

Pakningsvedlegg USA (FDA) - OxyContin (oxycodone hydrochloride) [Purdue Pharma L.P.] (FDA: DrugLabel) (Norge; OxyContin [Mundipharma AS].)

FDA beefs up pain-drug warnings in face of abuse epidemic
reuters.com 10.9.2013
(Reuters) - The U.S. Food and Drug Administration has proposed stronger safety language on labels of long-acting and extended-release opioids in response to an epidemic of overdoses and deaths from the widely used pain medicines.

The labels need to highlight dangers of abuse and possible death, as well as risks to newborns of mothers taking the medicines, the agency said on Tuesday.
Opioids include formulations of morphine, oxycodone and fentanyl. One of the best-known opioids is Oxycontin, a long-acting form of oxycodone.

Some 16,651 people in 2010 died from overdose deaths related to opioid abuse, the FDA said, including long-acting formulations.

In a conference call, FDA officials said long-acting forms of opioids have played a "disproportionate role" in drug abuse and deaths. (…)

(Anm: FDA Tightens Opioid Labeling (medpagetoday.com 10.9.2013).)

19-åring døde av smertestillende
nrk.no 2.8.2013
Oxycontin er en sterk smertestillende.

En 19 år gammel kvinne fra Tønsberg døde tirsdag etter å ha tatt ulike medisiner, blant annet en tablett av det morfinlignende medikamentet Oxycontin.

– Tabletten med Oxycontin hun fikk i seg kan ene og alene ha vært dødelig, sier politioverbetjent og leder for etterforskningsseksjonen Henning Fosaas til Tønsbergs Blad.

Kvinnen ble funnet av en venn hjemme hos et familiemedlem. Det ble også beslaglagt noen andre medikamenter der kvinnen ble funnet, men de skal ikke ha vært farlige.

Politiet mener hun fikk i seg en tablett med Oxycontin som var over 80 milligram. (...)

Rusforsker: Sjelden at noen dør av dette stoffet
vg.no 2.8.2013
Politiet: Jente (19) døde av smertestillende medisiner

Det blir ikke ofte registert dødsfall knyttet til Oxycontin, men leder Arild Knutsen i Foreningen for human narkotikapolitikk advarer sterkt mot medikamentet og kaller det livsfarlig.

Fredag ble det kjent at politiet i Tønsberg etterforsker hvordan en 19 år gammel jente fra distriktet døde etter å ha fått i seg det de mener er det sterke smertestillende stoffet Oxycontin.

Stoffet gis ved sterke smerter etter operasjoner, i forbindelse med skader og ved kreft. (...)

Oxycontin brukes på sykehus og kan skrives ut på såkalt A-resept (narkotika) til enkeltpasienter, opplyser Seniorrådgiver Christian Berg ved Nasjonalt folkehelseinstitutt. (...)

Overlege Liliana Bachs ved Folkehelseinstituttet forklarer at en overdose av Oxycontin fungerer på alle praktiske måter som en heroinforgiftning. (...)

FDA Updates OxyContin Label, Blocks Generics (FDA oppdaterer OxyContins preparatomtale, blokkerer generiske legemidler)
medpagetoday.com 16.4.2013
FDA har kommer med ny preparatomtale for OxyContin--på samme dag som patentet utløper på den opprinnelige formuleringen, og blokkerer dermed potensielle generiske versjoner av originalen som ikke har preventive egenskaper mot misbruk. (The FDA has issued new labeling information for OxyContin -- on the same day the patent on the original formulation expired, thus blocking potential generic versions of the original that do not have abuse-deterrent properties.)

Den nye preparatomtalen viser at produktet "har fysiske og kjemiske egenskaper som er forventet å gjøre misbruk via injeksjon vanskelig og redusere misbruk på intranasal måte (via nese) ," ifølge en pressemelding for FDA. (The new labeling indicates that the product "has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route," according to an FDA press release.)

I en uttalelse sier byrået (FDA) at de ikke vil godkjenne noen nye legemiddelsøknader for generiske legemidler som er basert på den opprinnelige formuleringen. (...) (In the statement, the agency said it will not approve any abbreviated new drug applications for generics that are based on the original formulation.)

Opana-produsenten, legemiddelfirmaet Endo Pharmaceuticals, hadde saksøkt FDA for å blokkere generiske versjoner av legemidlet, men søksmålet ble avvist. (Opana drugmaker Endo Pharmaceuticals had sued the FDA to block generic versions of the drug, but the lawsuit was dismissed.)

FDA halts generic OxyContin, handing Purdue a victory
fiercepharma.com 16.4.2013
Agency stops pain drugs on grounds that abuse risks are greater than benefit

For months FDA regulators have been wrestling with the dangers of allowing a flood of cheap, generic versions of the highly addictive OxyContin on the market versus the benefit of consumers with pain issues having access to cheaper meds. Legislators and law enforcement officials reasoned and pleaded with, or threatened, the FDA over approving them. Today as Purdue Pharma's patent for the original OxyContin expired, the FDA came down on their side, saying "the benefits of original OxyContin no longer outweigh its risks" and banned any copies from approval. (...)

Abuse Resistance an Issue with Opioid Generics
medpagetoday.com 3.1.2013
As patents on popular opioid painkillers OxyContin (oxycodone) and Opana (oxymorphone) start expiring, makers of the brand products warn that the potential non-tamper-resistant generics are unsafe, and some legislators are concerned as well.

Drugmakers Purdue and Endo Pharmaceuticals have taken steps to keep generic competition at bay, and late last month, Sen. Tom Coburn, MD, (R.-Okla.), a member of the Senate Homeland Security and Governmental Affairs Committee, and Rep. Fred Upton (R.-Mich.), chair of the House Energy and Commerce Committee, sent a letter to HHS Secretary Kathleen Sebelius asking for more information on the "imminent release of non-tamper-resistant versions of extended-release opioids and the impact ... on our nation's struggle against prescription drug abuse." (...)

Deaths tied to painkillers rising in the U.S. (Dødsfall knyttet til smertestillende legemidler øker i USA)
latimes.com 29.3.2013
The latest figures on overdoses come as pressure mounts to restrict use of prescription drugs such as OxyContin and Vicodin.

Despite efforts by law enforcement and public health officials to curb prescription drug abuse, drug-related deaths in the United States have continued to rise, the latest data show.

Figures from the U.S. Centers for Disease Control and Prevention reveal that drug fatalities increased 3% in 2010, the most recent year for which complete data are available. Preliminary data for 2011 indicate the trend has continued.

The figures reflect all drug deaths, but the increase was propelled largely by prescription painkillers such as OxyContin and Vicodin, according to just-released analyses by CDC researchers. (...)

Maine sore spot in nation's prescription drug scourge (Maine sårt punkt for nasjonens reseptbelagte legemiddelplage)
reuters.com 21.4.2011
(Reuters) - It was yet another pharmacy robbery in the small town of Sanford, Maine, where a woman claiming to have a gun said she would shoot if she didn't get the prescription painkiller OxyContin. (...)

One 80-milligram tablet of OxyContin, sometimes called "OC" or "hillbilly heroin," fetches up to $100 on the street.

OxyContin is the opiate-derived analgesic oxycodone made by Purdue Pharma. A generic version of oxycodone became available in 2004. (...)

CDC Links Prescription Painkillers in Pregnancy to Birth Defects (CDC linker reseptbelagte smertestillende midler i svangerskapet til fødselsdefekter)
news.yahoo.com 2.3.2011
WEDNESDAY, March 2 (HealthDay News) -- Moms-to-be who take prescription opioid painkillers such as codeine, hydrocodone or oxycodone (Oxycontin) may increase the risk of birth defects in their newborns, according to a new U.S. government report.

Taking these types of analgesics just prior to pregnancy or in the early stages of pregnancy was linked to a modest risk of congenital heart defects in an ongoing population study, according to the U.S. Centers for Disease Control and Prevention.

The risk for spina bifida, hydrocephaly, congenital glaucoma and gastroschisis was also heightened, the report said.

"Women who are pregnant, or thinking about becoming pregnant, should know there are risks associated with using prescription painkillers," said CDC Director Dr. Thomas R. Frieden, in an agency news release. "They should only take medications that are essential, in consultation with their health care provider." (...)

Risks: Pain Drugs May Lead to Birth Defects (Risikoer: Smertestillende legemidler kan føre til fødselsdefekter)
nytimes.com 17.3.2011
Women who take codeine, oxycodone and other opioid pain drugs early in pregnancy may be exposing their babies to a higher risk of birth defects, a new government study suggests.

Though the overall numbers were small, babies whose mothers took opioids were considerably more likely than others to have congenital problems, including a potentially fatal syndrome in which the left part of the heart does not develop completely; spina bifida, in which the backbone and spinal canal do not close; and gastroschisis, in which the intestines stick out of the body.

The study, from the Centers for Disease Control and Prevention, was one of the largest to examine the effects of opioid use during pregnancy. It appeared last month in The American Journal of Obstetrics & Gynecology.

It used data from the National Birth Defects Prevention Study about mothers in 10 states who gave birth from 1997 to 2005. Information was drawn from hourlong computer-assisted telephone interviews with the mothers. (...)

OxyContin gets a safety makeover
seattletimes.nwsource.com 1.4.2010
The Food and Drug Administration this week approved a new formulation for OxyContin. In its new form, OxyContin will be much harder to crush, cut, ground, chew or dissolve in liquid. It's hardly the answer to opioid addiction and abuse but a physician says it's a step in the right direction. (...)

FDA Panel Backs 'Black Box' Warning for Acetaminophen Prescription Combos
medpagetoday.com 30.6.2009
ADELPHI, Md. June 30 -- An FDA advisory panel voted 36 to 1 to recommend a "black box" warning for prescription medications that combine acetaminophen with another drug.

If the FDA follows the advice, it would slap its strictest warning on prescription pain medications that combine acetaminophen with hydrocodone (Vicodin), oxycodone (Percocet), or codeine (Tylenol 3).

A joint panel of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee voted for the warning after two days of hearings on ways to reduce acetaminophen's liver damage risk.

"History has been that some of these medications have [seemed] safe and effective and now we're saying they're not," said committee chairman Lewis Nelson, MD, an emergency medicine physician at New York University Medical Center. (...)

METHADONE-ASSOCIATED OVERDOSE DEATHS
United States Government Accountability - Office Report to Congressional Requesters
gao.gov (GAO-09-341) (March 2009)
Factors Contributing to Increased Deaths and Efforts to Prevent Them (...)

One of the key factors in the spike in methadone-associated deaths is the rising number of methadone prescriptions intended for pain management since the late 1990s, after the abuse and deaths associated with OxyContin were widely publicized, the report concluded. (...)

For additional information regarding OxyContin abuse and diversion, see GAO, Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem, GAO-04-110 (Washington, D.C.: Dec. 23, 2003).

Congress Presses FDA on Investigations
online.wsj.com
WASHINGTON -- The criminal-investigations wing of the Food and Drug Administration is in hot water with Democrats and Republicans in both the Senate and the House.

The Office of Criminal Investigations, or OCI, has operated largely autonomously in recent years, emphasizing a crackdown on illegal abuse of drugs such as Oxycontin. Its budget doubled to $42.8 million from fiscal 2000 to fiscal 2009, even as FDA officials were conceding that funds for assuring the quality of imported drugs weren't adequate. Monday, the Bush administration announced it would ask Congress for an extra $275 million to beef up FDA inspections. (...)

3 Executives Spared Prison in OxyContin Case (Tre ledere skånet for fengselstraffer)
nytimes.com 20.7.2007
ABINGDON, Va., July 20 — After hearing wrenching testimony from parents of young adults who died from overdoses involving the painkiller OxyContin, a federal judge Friday sentenced three top executives of the company that makes the narcotic to three years’ probation and 400 hours each of community service in drug treatment programs.

In announcing the unorthodox sentence, Judge James P. Jones of United States District Court indicated that he was troubled by his inability to send the executives to prison. But he noted that federal prosecutors had not produced evidence as part of recent plea deals to show that the officials were aware of wrongdoing at the drug’s maker, Purdue Pharma of Stamford, Conn. (...)

Fire milliarder i "heroin"-bot
e24.no 13.5.2007
Falsk markedsføring førte til at mangfoldige personer ble avhengig av "fattigmannsheroin".

MIRAKELMEDISIN: Legemiddelprodusenten markedsførte den sterke smertestilleren OxyContin som en "mirakelmedisin". Problemet var bare at den ikke var det. (...)

Det amerikanske legemiddelselskapet Purdue Pharmaceuticals ble nylig dømt til å betale en erstatning på 635 millioner dollar, eller 3,9 milliarder kroner, for falsk markedsføring av det sterke smertestillende legemiddelet OxyContin.

Selskapet og tre toppsjefer sa seg skyldige i falsk markedsføring, skriver Washington Post. (...)

OxyContin maker misled on addiction risks (Produsenten av OxyContin villedet om risiko for avhengighet)
msnbc.msn.com 10.5.2007
Purdue Pharma and former executives to pay $634.5 million in fines
NBC video

ROANOKE, Va. - The maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty Thursday to misleading the public about the drug’s risk of addiction, a federal prosecutor and the company said.

Purdue Pharma L.P., its president, top lawyer and former chief medical officer will pay $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said in a news release.

The plea agreement comes two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin. (...)

False information
Purdue learned from focus groups with physicians in 1995 that doctors were worried about the abuse potential of OxyContin. The company then gave false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers, the U.S. attorney said.

Privately held Purdue Pharma said it accepted responsibility for its employees’ actions.

“During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again,” the company said in a news release. (...)

OxyContin Makers Admit Deception
washingtonpost.com 11.5.2007
Addiction Danger From Painkiller Was Understated

The manufacturer of the potent painkiller OxyContin and three current and former executives at the company yesterday pleaded guilty to falsely marketing the drug in a way that played down its addictive properties and led to scores of people becoming addicted, prosecutors said.

The Purdue Frederick Co. and its chief executive, top lawyer, and former medical chief agreed to pay a total of $635 million to resolve charges filed by the U.S. attorney in the Western District of Virginia, who called OxyContin "one of our nation's greatest prescription-drug failures."

"Even in the face of warnings from health-care professionals, the media and members of its own sales force . . . Purdue continued to push a fraudulent marketing campaign," U.S. Attorney John L. Brownlee said. (...)

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kundeweb.aggressive.no (mundipharma - Nyhetsbrev nr. 2006)
- Det er ingen grunn til å frykte tilsynsmyndigheten når du som lege forskriver
vanedannende legemidler for å gi pasienten en effektiv behandling, sier avdelingsdirektør Jørgen Holmboe i Statens helsetilsyn. Det avgjørende er at behandlingen dokumenteres og at pasienten får en tett oppfølging av deg som lege.(...)

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