U.S. Food and Drug Administration has announced that Xanodyne Pharmaceuticals, maker of painkillers Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, with withdraw the drugs from the U.S. market after the FDA requested the withdrawal.
The FDA is also asking generic manufacturers of propoxyphene-containing products to voluntarily remove their products as well.
The decision by the FDA to request withdrawal of the medication sought market after receiving new clinical data indicating the drug increases risk of potentially serious or even fatal heart rhythm abnormalities.
“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” said John Jenkins, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, according to an FDA news release. “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.”
Read the FDA news release about propoxyphene.
