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Drugs that contain the pain-killing ingredient propoxyphene -- including the popular prescription medications Darvon and Darvocet -- will need to carry stronger warnings and detailed instructions on safe use by patients, under orders issued today by the U.S. Food and Drug Administration (FDA).
The action is aimed at reducing the growing number of fatal overdoses linked to drugs containing propoxyphene, and it's part of the FDA's larger effort to appropriately assess and regulate the safety of painkiller medications flooding the U.S. drug market.
"Prescribers and patients should be aware of propoxyphene's potential risks when used at doses higher than those recommended," Janet Woodcock, M.D, director of the FDA's Center for Drug Evaluation and Research said in an FDA News Release on the Darvon and Darvocet Order. "Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy," Woodcock added.
The FDA also ordered a new study that will address "unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses," and the results of that study could prompt additional regulatory action.
Darvon and Darvocet, are propoxyphene prescription pain medications used to relieve mild to moderate pain, but they can also be addictive and carry a high risk of abuse.
The FDA orders issued today were prompted in part by a petition filed by the consumer group Public Citizen, which had asked the FDA to remove Darvon and Darvocet from the market, the Wall Street Journal is reporting. The group alleges that Darvon and Darvocet have been linked to at least 2,000 accidental overdose deaths.
Today's FDA action comes a week after an FDA advisory panel recommended that Vicodin and Percocet be pulled from the market, and that safe dosage levels be lowered for OTC acetaminophen drugs like Tylenol and Excedrin.
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