November 19, 2010 – According to an FDA announcement, Xanodyne Pharmaceuticals Inc. has agreed to withdraw its prescription pain medications Darvocet and Darvon from the market. The FDA also asked generic makers of the pain medicine to voluntarily remove their products. “The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks,” the FDA said in today’s statement. The move to recall comes after the drugs’ active ingredient propoxyphene was found to put patients at risk of developing potentially fatal heart rhythm abnormalities which can then lead to heart attacks and/or other significant heart related problems.

“We recommend physicians stop prescribing the drugs. As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay,” said Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology.

What is Darvon and Darvocet?

Darvon (propxyphene) was first introduced in 1957 as a mild pain reliever.

Darvocet was introduced as a combination drug that contained both propxyphene and acetaminophen, the active ingredient in Tylenol. At the time of the recall, Darvocet was one of the most commonly prescribed medications in the United States.

Although experts have been indicating for years that a recall of Darvon and Darvocet should be issued, the medications were sold to millions of Americans without adequate warnings about the risk of injury or death.