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From: ABC The U.S. Food and Drug Administration has called for a boxed warning of overdose risk on packages of Darvon, Darvocet and other painkillers containing the drug propoxyphene -- but it will not order their withdrawal from the market.
The agency ordered manufacturers to study higher-than-expected fatality rates in propoxyphene overdoses compared with other painkillers -- and possible toxic effects on the heart in when consumers exceed recommended doses.
However, the FDA rejected a petition from the consumer group Public Citizen calling for phased withdrawal of these products.
In its action, announced during a press briefing on Tuesday, the agency rejected the advice of its own advisory panel, which voted 14-12 for a ban on propoxyphene products because of overdose risk and doubts about their painkilling effectiveness.
Propoxyphene is an opioid painkiller chemically similar to methadone. Some pain specialists, such as Dr. Lloyd Saberski of the Yale-New Haven Hospital in Connecticut, criticize propoxyphene as a weak narcotic with no place on the shelf. |
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Read more... [FDA Slaps Strong Warning on Darvon, Darvocet]
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By THE ASSOCIATED PRESS Government medical advisers recommended a ban on Darvon, a prescription drug that has been used to treat pain for more than 50 years but has been linked to addiction. An advisory panel to the Food and Drug Administration voted 14 to 12 to recommend its withdrawal. The F.D.A. is not required to follow such recommendations, but often does. Darvon, approved in 1957 and now mainly marketed as Darvocet, is one of the 25 most commonly prescribed medications. Public Citizen had petitioned the F.D.A. to withdraw Darvon, saying the drug offered relatively weak pain relief and posed an overdose risk. Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, which market the drug, say the medication is safe and effective when used as directed. |
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