FDA Warns of Darvocet, Darvon Overdose Risks
Moving to reduce the risks of deadly overdoses in patients taking Darvocet, Darvon, and other pain medications including the drug propoxyphene, the Food and Drug Administration today is taking several actions against makers of the drugs.
While stopping short of ordering recalls of the painkillers, the FDA is requiring their makers to include stronger warnings on the products’ labeling about the risks of overdose. Manufacturers of propoxyphene products must also provide medication guides to patients to emphasize the importance of taking the drugs as directed and conduct additional studies of the effects of propoxyphene on the heart when the drug is used at higher-than-recommended doses, the FDA said.
Propoxyphene has been used in Darvocet, Darvon, and other drugs since 1957 for treating patients with mild to moderate pain. The FDA said it still considers the benefits of propoxyphene to outweigh any potential risks to users, so the drugs are not being removed from the market.
The FDA, in announcing the new labeling and research requirements for makers of the medications, denied a petition filed by consumer advocacy group Public Citizen asking for propoxyphene to be withdrawn from the U.S. market.
FDA Advisory Panel Has Recommended Ban
In January, an advisory FDA panel narrowly recommended the agency ban Darvon and Darvocet, in part because of the risks of fatal overdoses and the existence of newer, safer pain medications. While the FDA generally follows the advice of its expert panels, this time, the FDA is leaving the controversial pain medications in circulation. Only time will tell if that is a prudent move.
The drugs have been associated with severe complications in some users, prompting officials around the world to impose bans and restrictions on its use.
The FDA is advising physicians to be aware of the risk of overdose when prescribing Darvocet, Darvon, and other propoxyphene medications. Patient histories should be considered to determine whether the painkillers are safe and effective.
Drug-safety officials said they will continue monitoring the category of pain drugs and may announce further regulatory actions in the future.
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