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.

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.

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.

  • FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene (FDA.gov)
  • WSJ: FDA Requires Boxed Warning On Darvon, Darvocet Pain Pills
  • Darvon/Darvocet: Health and Legal Information (FindLaw)
  • Pharmaceutical Litigation (provided by Abraham, Watkins, Nichols, Sorrels, Agosto & Friend)
  • Vicodin, Percocet Bans May Be on the Way (FindLaw’s Injured)
  • The High Cost of Product Defects (provided by Law Offices of Smith & Doran)

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