The FDA also urged the makers of generic versions of the two drugs to pull them from the market as well.
"We recommend to physicians stop prescribing the drugs," said Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology. "As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay."
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That all changed this year, after the FDA reviewed the results of a clinical study that raised increasing concern over heart risks.
Propoxyphene is sold as Darvocet when combined with acetaminophen.
Xanodyne Pharmaceuticals Inc. is the manufacturer of the Darvon and Darvocet brands—two drugs that have been prescribed (including generics) to 10 million people since 2009.
"The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," the FDA said in a statement released Friday.