Darvocet Pulled Off The Market

Xanodyne Pharmaceuticals has agreed to pull Darvocet and Darvon off the market after an FDA study found the drug can cause abnormal heart rhythm problems.

Darvon and Darvocet are the brand names for Xanodyne's prescription pain medicine, propoxyphene. They are synthetic narcotics used to influence the brain's ability to reduce the feelings of mild to moderate pain. The FDA conducted a study that found propoxyphene causes significant changes to the electrical activity of the heart and can result in potential heart attack, if not sudden death.

Darvon is a prescription drug that was introduced to the public in 1957 by Eli Lilly to relieve post-surgical pain. The drugs are marketed as generics by Xanodyne Pharmaceuticals. In 2007, it was one of the top 25 most commonly prescribed medicines and was used by more than 22 million people. In 2005, the UK began a phased withdrawal of the drug and it was removed completely off the market by 2007.

“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,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “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.”

The US Food and Drug Administration recommends that doctors should no longer prescribe the medicine to patients and that those patients who are taking the drug should see their health care professional as soon as possible.

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