Propoxphene, a prescription pain medication, has been withdrawn from the market after the FDA reported new clinical data that showed the drug my cause potentially serious or even fatal heart rhythm abnormalities.
Xanodyne Pharmaceuticals Inc., the maker of the drug, and other generic manufacturers of propoxphene-containing products have agreed to comply with the FDA and withdraw the medication from the U.S. market.
After reviewing the clinical data, the FDA issued a statement that shows they concluded that the risks of the medication far outweighed the benefits
The FDA is pleased by Xanodynes 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 FDAs Center for Drug Evaluation and Research (CDER). These new heart data significantly alter propoxyphenes risk-benefit profile. The drugs effectiveness in reducing pain is no longer enough to outweigh the drugs serious potential heart risks.
Clinical data of the drug, which was approved in 1957 and was used to treat mild to moderate pain, showed that even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart and may increase the risk for a serious abnormal heart.
