FDA: Propoxyphene Withdrawn From U.S. Market

Drug being withdrawn due to risk of serious or even fatal heart rhythm abnormalities

FRIDAY, Nov. 19 (HealthDay News) -- At the request of the U.S. Food and Drug Administration, Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene, an opioid used to treat mild to moderate pain, from the U.S. market due to the risk of potentially serious or even fatal heart rhythm abnormalities.

Propoxyphene is sold by prescription as a single agent (Darvon) or in combination with acetaminophen (Darvocet). The FDA recently sought to request withdrawal of propoxyphene from the market, as the agency concluded that the risks of propoxyphene outweighed the benefits of the drug. New clinical data presented to the FDA revealed the potential of heart rhythm abnormalities related to the drug.

Generic manufacturers of propoxyphene-containing products have also been informed and the agency has requested that they remove their products from the market as well. The FDA has received two requests to remove the drug from the market since 1978, but until now it had determined that the benefits outweighed the risks.

According to an agency safety alert, "the FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy."

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