Health & Medical Dental & Oral

FDA Recall - Propoxyphene (Darvon and Darvocet) Taken Off the Market

Updated December 29, 2014.

At the request of the U.S. Food and Drug Administration (FDA), Xanodyne Pharmaceuticals Inc., makers of Darvon and Darvocet, pulled the drug off the market. The FDA also informed generic makers of the drug propoxyphene to voluntary stop production as well. Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

The recall was issued after clinical data demonstrated propoxyphene puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of the data, combined with information including new epidemiological data, the FDA concluded that the risks of the medication outweigh the benefits. According to a press release "The FDA is pleased by Xanodyne's decision to voluntarily remove its products from the U.S. market," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "These new heart data significantly alter propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."

The FDA is also urging health care professionals to stop prescribing Darvon and Darvocet. Both drugs are typically prescribed after dental surgery, such as wisdom teeth extractions. If you have either Darvon, Darvocet, or a generic form of propoxyphene in your medicine cabinet, stop using the medication and speak to your dentist or physician immediately.

The following are some of the drugs that contain propoxyphene:
  • Darvocet A500
  • Darvocet-N
  • Darvocet-N 100
  • Darvocet-N 50
  • Darvon
  • Darvon-N 100
  • Darvon-N

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