At the request of the FDA, the manufacturer of the prescription pain medication propoxyphene has agreed to withdraw the medication from the U.S. market. It is sold under the brand names Darvon and Darvocet, according to a November 19 FDA new release.
The FDA sought market withdrawal of propoxyphene, an opioid manufactured by Xanodyne Pharmaceuticals Inc., Newport, Ky., after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of those findings, and in light of other information, including new epidemiological data, the agency concluded the risks of the medication outweigh the benefits.
“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” John Jenkins, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER), stated in the 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.”
In a related development, the FDA has informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they also voluntarily remove their products from the market.
Health care professionals are being advised by the FDA to stop prescribing propoxyphene to their patients and patients currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy, according to the release.
The efficacy and safety of propoxyphene, first approved by the FDA in 1957, was the subject of a January 2009 FDA advisory committee meeting. After considering the data submitted with the drug’s original application and subsequent medical literature and post-market databases, the committee voted 14 to 12 against continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac events would be relevant in weighing its risks and benefits, based on the release.
A phased withdrawal of propoxyphene is underway in Europe where in June 2009 the European Medicines Agency recommended that the marketing authorizations for propoxyphene issued there be withdrawn across the European Union.
In the press release, Director of the Office of Surveillance and Epidemiology, CDER, Gerald Dal Pan, MD, MHS, stated, “With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart.
“However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away,” he stated.