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Home / Uncategorized / FDA Recalls Painkilling Drugs Darvon and Darvocet

FDA Recalls Painkilling Drugs Darvon and Darvocet

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The Food and Drug Administration (FDA) has removed some risky painkillers from the market. Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has been withdrawn the from the U.S. market. The FDA has finally determined that serious potential heart risks far outweighed the minimal medical benefits.

Propoxyphene is an opioid used to treat pain. It was first approved by the FDA in 1957. Propoxyphene is sold by prescription under the names Darvon and Darvocet. Darvocet also contains acetaminophen.

New clinical data on propoxyphene shows that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. The UK banned propoxyphene about 8 years ago. The US Food and Drug Administration moved very slowly on this matter.

An FDA advisory committee met to address the efficacy and safety of propoxyphene. The committee voted 14 to 12 against the continued marketing of propoxyphene products. The potential of abnormal or even fatal heart rhythm abnormalities were critically relevant in weighing the risks to the benefits of the drug.

Source: FDA NEWS RELEASE, Xanodyne agrees to withdraw propoxyphene from the U.S. market, November 19, 2010.

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