Propoxyphene gets boxed warning.(NEWS FROM THE FDA)(Brief article)

To reduce the risk of fatal propoxyphene overdoses, the FDA 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 Department of Veterans Affairs to study the safety of Darvocet.

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.

The FDA also is requiring that manufacturers now provide a medication guide that explains the risks of propoxyphene; this will be provided to patients with each prescription, including refills.

In a narrow 14-12 vote in January, 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.

The agency issued a statement saying that "FDA recognizes that there are unanswered questions about the safety of propoxyphene when used at doses higher than recommended in the label. These unanswered questions include effects on the heart in overdose."

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