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Darvon pulled after 50 years
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Need we say more about which side the FDA is on? There were over
35 million scripts written for Darvon and Darvon with acetaminophen (Darvocet)in 2007. Unfortunately the same
occurs around the world. It took to 2005 for the UK to pull the drug (one of
the advantages of a managed health system). But there is a major global assault
by the industry and financial sectors to eliminate government intervention in business including the health system. Slowly because of public sentiment, it is being dismantled in the developed world with the exception of
the US where the legislation proposed had the guidance of the big PhARMA and insurance industries--jk. FiercePharma,
Jan 30. 2009, by Tracy Staton Another set of pain pills faces possible extinction because
of abuse: The FDA is asking an advisory committee to weigh in on whether to keep Darvon and Darvocet meds on the market. Darvon (propoxyphene) was originally developed by Eli Lilly
and has been on the market for more than half a century. Darvocet combines Darvon's active ingredient with acetaminophen.
Both meds are sold as generics now, and more than 20 million scripts were
written for products containing their So what's the beef? Consumer watchdog Public Citizen petitioned the FDA
to get the products banned, then sued when the agency didn't act. The lawsuit cited data implicating propoxyphene in 5.6 percent
of the drug related deaths from 1981 to 1999. Plus, Public Citizen claims, the products are "relatively weak" painkillers,
and they're toxic at only slightly more than the recommended dosage. FDA says it found 1,452 deaths associated with propoxyphene
from 1957 through September 2008, but some of those reports listed more than one drug. Two of the generics makers selling
the propoxyphene products--Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals--say they're safe and effective
when used as directed, and they pointed out that more than 600 million scrips for the drugs have been dispensed over the past
50 years Wall Street Journal |
Health section, Darvon has been on the market since 1957, and Saturday marks
the 30th anniversary of the first congressional hearing on its safety. Nonethless, it still enjoys wide use in treating mild
to moderate pain. More than 20 million prescriptions were written in 2007 for products containing propoxyphene, the active
ingredient in Darvon, according to the FDA. The panel voted 14-to-12 that the drug's benefits didn't
outweigh its risks, and called for removal from the Darvon's defenders argue it is safe and effective when used
as directed. The label warns against taking it in combination with alcohol or certain other drugs. Darvon was developed by Eli Lilly & Co., which later combined propoxyphene with acetaminophen,
the active ingredient in Tylenol, and sold that pill as Darvocet. Today the drugs are marketed by generic-drug makers. Sidney Wolfe, a doctor at the advocacy group Public Citizen,
has been fighting Darvon since the late 1970s, and triggered Friday's panel meeting with a petition and a lawsuit that sought
to force the FDA to ban the drug. In its petition, Public Citizen cited data from the Drug
Abuse Warning Network implicating propoxyphene in 5.6% of drug-related deaths from 1981 to 1999. Public Citizen also said
the network reported 2,110 accidental deaths related to propoxyphene over the same period. The FDA also cited reports of serious events such as suicides,
intentional and unintentional overdoses and heart attacks. But the agency's analysts said the evidence wasn't conclusive enough
to ban Darvon. In an interview about Darvon before Friday's meeting, Dr.
Wolfe said, "Claims of its efficacy have been seriously undercut by the FDA's own analysis." He noted that the agency said
Darvon "possesses weak analgesic effects." In his presentation Friday, Dr. Wolfe presented updated data
showing 503 deaths in 2007 in which propoxyphene was listed as a contributing factor. "All drugs have risks," Dr. Wolfe said.
"If they don't have benefits they need to come off the market." |
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32
years after Public Citizen first partitioned the FDA to pull the ineffective and dangerous Darvon, they finally did From FiercePharma by Tracy Staton November
22, 2010 After years of debate over their safety, FDA has moved to withdraw painkillers
Darvon and Darvocet, plus the multitude of generic copycats. Why now? The agency says it received new data showing that propoxyphene,
an active ingredient in both drugs, increases the risk of serious--even fatal--abnormal heart rhythms. "These new heart data significantly alter propoxyphene's risk-benefit profile,"
the FDA's John Jenkins says in a statement. "The drug's effectiveness in reducing pain is no longer enough to outweigh the
drug's serious potential heart risks." Some would argue that the risk-benefit profile has been stacked too heavily on
the risk side for years. Potentially addictive, the drug is also difficult to dose, because there's a fine line between
an effective dose and a toxic one, the New York Times notes. The consumer watchdog Public Citizen started agitating
for Darvon's demise back in 1978. Then, in 2005, the U.K. yanked propoxyphene drugs on worries about overdosing. Public Citizen
followed up with another petition for withdrawal in 2006. Last year, European regulators advised withdrawal; soon after, an FDA advisory
panel recommended that the agency pull the drugs off the market, but the agency decided to put a boxed warning on them instead.
At the time, FDA asked Darvon's maker, Xanodyne, to conduct a new study--and that's the study that unveiled the heart-rhythm
troubles. The agency now is asking physicians to stop prescribing the drugs and recommends patients contact their doctors
about alternatives. - get the statement from
FDA FDA Statement at http://www.fiercepharma.com/press_releases/xanodyne-agrees-withdraw-propoxyphene-us-market-0?utm_medium=nl&utm_source=internal Xanodyne
Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene,
has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA
has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne's decision and requested that
they voluntarily remove their products as well. The
FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk
of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information,
including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits. "The
FDA is pleased by Xanodyne's decision to voluntarily remove its products from the U.S. market," said John Jenkins, M.D., director
of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "These new heart data significantly
alter propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's
serious potential heart risks." The
FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently
taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management
therapy. Propoxyphene
is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription
under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet). Since
1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the
benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug. In
January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering
the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing
safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation,
the committee noted that additional information about the drug's cardiac effects would be relevant in weighing its risks and
benefits. In
June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn
across the European Union. A phased withdrawal of propoxyphene is underway. In
July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label
alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne
to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart. The
agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes
significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG),
can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden
death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have
taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration,
a change in medications, or decreased kidney function. "With
the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can
be harmful to the heart," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER.
"However, long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative.
Once patients stop taking propoxyphene, the risk will go away." Xanodyne
is based in Newport, Ky. |