Legal News

The painkillers Darvon and Darvocet have been pulled from the market, according to the U.S. Food and Drug Administration. According to new data, propoxyphene, the main ingredient can cause serious or even fatal heart rhythm abnormalities.

The FDA has asked Xanodyne Pharmaceuticals Inc. to pull both Darvon and Darvocet from the market. The drugs have been banned in Britain for six years.

Dr. John Jenkins of the FDA's Center for Drug Evaluation and Research said using propoxyphene is not worth the risks: "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."

Some doctors are saying propoxyphene should have been pulled in the U.S. years ago. The European Medicines Agency pulled it from the market in June 2009, Reuters reports. Dr. Sidney Wolfe of the Public Citizen's Health Research Group said that "Due to FDA negligence, at least 1,000 to 2,000 or more people in the United States have died from using propoxyphene since the time the U.K. ban was announced."

At this time, the FDA is calling for doctors to stop issuing prescriptions, but it said that patients should continue taking the recalled drugs until told otherwise and they should immediately schedule an appointment with their doctor to discuss alternatives.

The FDA does not believe that the risks of the drug will be long term. "Once patients stop taking propoxyphene, the risk will go away," said FDA's Dr. Gerald Dal Pan.

Related Resources:

• No more Darvon for U.S. market: FDA (Reuters)
• Food and Drug Administration(FindLaw's LawBrain)
• Novartis to Pay $422M in Improper Off-Label Marketing Settlement (FindLaw's Decided)

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