Painkillers Darvon and Darvocet Withdrawn From U.S. Drug Market

Propoxyphene, the generic name for Darvon, is a painkiller that has been available by prescription in the United States since 1957. "The Washington Post" reports that, as of Nov. 19, 2010, Darvon was pulled from the market in response to a request by the U.S. Food and Drug Administration to do so.

In the FDA's safety report, posted the same date as the medication was withdrawn by Xanodyne Pharmaceutical, the agency lists concerns about heart toxicity concerns in otherwise healthy patients taking the pain medication within therapeutic range. Pharmaceutical companies manufacturing and distributing the generic form of the drug will follow Xanodyne's lead and also withdraw the medications from the market.

Darvon is propoxyphene; Darvocet is propoxyphene combined with acetaminophen. Propoxyphene is an opioid drug used for the treatment of mild to moderate pain.

Propoxyphene has had its detractors for a long period of time in the United States, including an FDA advisory committee that, in July 2009, advised the FDA to withdraw the medication from the market due to its addictive nature. The FDA responded to that advice by requiring manufacturers to include stronger label warnings on the risk of overdose with the drug.

In a safety report released July 2009, the FDA stated that, at that time, the benefits of the pain medication outweighed the potential risks. Thus, it was not requested to be pulled from the market. The agency also advised it would be seeking more information on the safety of propoxyphene, requiring Xanodyne Pharmaceutical to conduct studies on the effect of propoxyphene on the heart if used in higher-than-recommended doses. It was the result of that study showing the risks to the heart that prompted the agency to call for the drug's withdrawal from the market in November 2010.

"The Washington Post" reports that Britain pulled propoxyphene from the market six years ago, with the rest of Europe doing so a year ago.

The Public Citizen's Health Research Group has long advocated removing propoxyphene from the market and feels the FDA took too long to act on the citizens' behalf, while the FDA feels the November 2010 ruling demonstrates they are flexible, willing to change their rulings and looking out for the health and safety of U.S. consumers.

Sources: Rob Stein, Controversial Painkiller Darvon Pulled at FDA's Request, "The Washington Post"
Propoxyphene Questions and Answers: July 2009, U.S. Food and Drug Administration
Propoxyphene: Withdrawal -- Risk of Cardiac Toxicity, U.S. Food and Drug Administration