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].)
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. (...)
Vanedannende legemidler:
Effektiv behandling krever god dokumentasjon
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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