FRIDAY, Nov. 19 (HealthDay News) -- The opioid-based painkillers Darvon and Darvocet are being withdrawn from the U.S. market because they've been linked to serious and potentially deadly heart rhythms, federal officials said Friday.
The U.S. Food and Drug Administration said Xanodyne Pharmaceuticals -- which makes Darvon and Darvocet -- is voluntarily taking the drugs off the market. The active ingredient in these drugs is propoxyphene. The agency has also asked the makers of generic versions of propoxyphene to remove them from the market.
"We have recently completed our review of a new clinical trial that was designed to assess the impact of propoxyphene on the electrical activity of the heart," Dr. John Jenkins, director of FDA's Office of New Drugs, Center for Drug Evaluation and Research, said during a Friday press conference. The trial showed propoxyphene can cause potentially serious or even deadly heart rhythm problems, called arrhythmias, he said.
"We concluded the pain benefits of propoxyphene no longer outweighed the heart risk and that propoxyphene should no longer be sold in the United States," Jenkins said.
In 2009, the European Medicines Agency recommended withdrawing the drug across the European Union. A phased withdrawal is under way, the FDA said.
Dr. Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology, said the agency is asking doctors to stop prescribing propoxyphene.
"We are advising patients who are currently taking the drug not to stop taking propoxyphene right away. You still need to manage your pain. Instead, we urge you to contact your health care professional as soon as possible to discuss switching to another pain-management therapy," he said.
Dal Pan said patients taking the drug who experience heart palpitations, dizziness or light-headedness should contact their doctor right away.
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