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Schachter, Hendy & Johnson, Attorneys At Law

Darvocet pulled for link to heart damage by the FDA

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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.

 

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