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Propoxyphene products stay on the market, but safety studies needed.

To reduce the risk of fatal propoxyphene overdoses, the Food and Drug Administration is mandating that manufacturers of propoxyphene-containing pain products add risk information to the boxed warning in product labels.

The agency also is requiring manufacturers to conduct a new study on the cardiac safety of the drug at higher than recommended doses.

Propoxyphene, an opioid, has been available since 1957, and is best known as Darvon and Darvocet (propoxyphene plus acetaminophen), but there are multiple generic formulations.

Other plans to address the risk include collaborating with the Centers for Medicare and Medicaid Services to study the safety and prescribing patterns for these products in the elderly population. The agency also will work with the Veterans Affairs to study the safety of Darvocet. The study will include a comparison of the combination drug's safety profile with that of other drugs. Data from these studies could result in additional actions by the FDA, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said during the briefing.

The available data suggest that the risk of a fatal overdose is higher with propoxyphene than with overdoses of other medications used to treat pain.

In an accompanying written statement, Dr. Woodcock said clinicians should be aware of overdose risks when prescribing these drugs, and that they, along with patients, "should be aware of propoxyphene's potential risks when used at doses higher than those recommended." The FDA also is requiring that manufacturers now provide a medication guide explaining the risks of propoxyphene; this will be provided to patients with each prescription, including refills.

The review of propoxyphene's safety was prompted by a Citizen Petition to the FDA filed in February 2006 by the health advocacy group Public Citizen. Propoxyphene has a cardiotoxic metabolite and has been associated with 2,110 reported accidental deaths in the United States from 1981 through 1999, according to Public Citizen. The FDA denied the group's request for a phased withdrawal of these products because of their risks (Public Citizen did not immediately issue a response to the FDA's announcement.)

In a narrow 14-12 vote in January 2009, an FDA advisory panel recommended that the risk-benefit profile for these products did not support their continued marketing for the treatment of patients with mild to moderate pain. But during the briefing, Dr. Woodcock said that, while the agency recognizes that there are unanswered questions about propoxyphene safety, it "is an acceptable choice for the treatment of mild to moderate pain, when taken as directed." And she added that the agency believed that propoxyphene provides "some additive pain relief over acetaminophen."

The European Medicines Agency recently recommended a phased withdrawal of propoxyphene products from the market.

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Title Annotation:NEWS FROM THE FDA
Publication:Family Practice News
Date:Aug 1, 2009
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