Saturday, November 20, 2010

Darvon Pulled From Market by F.D.A.

The painkilling drug propoxyphene, sold under the Darvon and Darvocet brands and used by about 10 million Americans last year, will be removed from the market because of serious heart risks, the Food and Drug Administration said on Friday.

The announcement ended a 32-year dispute over the safety of the 53-year-old drug. The F.D.A. recommended doctors switch patients to other painkillers, notably Extra Strength Tylenol or acetaminophen.

Propoxyphene has been shown to have very little effect on pain. Many studies showed no significant improvement by adding it to acetaminophen. Propoxyphene also has a narrow margin of safety between the recommended dose and a harmful dose or fatal overdose, according to the F.D.A. review and other experts.

Yet the drug, an opioid with addictive qualities, was the 38th-most prescribed generic drug in 2009 with 17.5 million prescriptions nationwide, according to SDI/Verispan, an information company. But as safety concerns intensified, sales declined by 14 percent last year over 2008. In earlier years, it had remained popular and in wider use in the United States, despite actions taken overseas and accumulating evidence of its hazards. Britain banned it in 2005 and the European Union followed in 2009, based partly on reports of an unusual number of deaths involving propoxyphene in Florida, where medical examiners do more toxicology work.

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