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FDA asks for removal of propoxyphene from the market

On Friday, November 19, 2010, the U.S. Food and Drug Administration asked Xanodyne Pharmaceuticals, Inc. to withdraw the brand name medications Darvocet and Darvon (generic name propoxyphene) from the U.S. market due to possible risk of heart rhythm abnormalities. The FDA is also asking that all manufacturers of the generic medications that contain propoxyphene withdraw their products as well.

Propoxyphene is an opioid pain medication prescribed to manage mild to moderate pain. It was first approved by the FDA in 1957 and has been manufactured by itself (Darvon) and in combination with acetaminophen (Darvocet).

In 1978, the FDA received two requests for the removal of propoxyphene from the market. At that time, the FDA concluded that the benefit of the medication outweighed its possible risks.

In January 2009, the FDA held an advisory committee to consider the safety and efficacy of propoxyphene. After reviewing data submitted with the original drug application and subsequent data and clinical studies performed, the FDA concluded that propoxyphene would remain on the market but issued a recommendation that the cardiac risks of propoxyphene be considered when weighing risks and benefit.

In June 2009, the European Medicines Agency recommended that propoxyphene be withdrawn across the European Union. A phased withdrawal is currently underway.

In July 2009, the FDA required that a new warning be added to the drug label for propoxyphene alerting patients to the potential for fatal overdose. Also, the FDA required that Xanodyne conduct new safety study addressing rising concerns about the propxyphene’s effect on the heart.

Now with the new data from Xanodyne’s safety study, the FDA has recommended the withdrawal of propoxyphene from the market. All healthcare professionals are being asked to stop prescribing propoxyphene as soon as possible and switch patients to a new pain management therapy. Patients currently taking propoxyphene should contact their health care provider and discuss new treatment.

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