SILVER SPRING, Md. A drug maker will pull a common prescription painkiller from the market following the release of clinical data that it could cause heart problems.
The Food and Drug Administration announced that it had requested the withdrawal of branded and generic versions of propoxyphene from the U.S. market due to the risk among patients of serious or fatal heart rhythm abnormalities. Xanodyne Pharmaceuticals markets the drug under the brand names Darvon and Darvocet –– a combination of propoxyphene and acetaminophen –– and several generic drug makers have their own versions. All the manufacturers will be removing the drug from the market, the FDA said.
“[The FDA] is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” FDA Office of New Drugs director John Jenkins said. “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 drug is used to treat mild to moderate pain and has been on the market since the late 1950s.