FDA pulls painkiller drugs Darvon and Darvocet from the market

The Food and Drug Administration (FDA) announced they have pulled painkiller drugs Darvon and Darvocet from the market, following new clinical research that shows the drug can cause heart side effects.

The FDA also ordered generic drug makers to stop marketing low-cost drugs containing the active ingredient in Darvon, called propoxyphene.

The study tested patients with electrocardiography and showed that QT interval abnormalities occurred in healthy people taking normal doses of the drug.

The medications cite propoxyphene as their main ingredient. Propoxyphene, an opioid is used to treat mild to moderate pain, was first approved by the FDA in 1957, but has been questioned for years for safety concerns.

Kentucky-based Xanodyne Pharmaceuticals Inc, said it has been working with the U.S. FDA since January 2009 to produce a patient medication guide, strengthen several warnings in product labeling and conduct a clinical study to assess the maximum tolerated dose and effects of propoxyphene.

The FDA has was given two requests to recall the drug from the market since 1978 but had previously concluded the benefits outweighed the risks.

Since 2005, approximately 120 million prescriptions have been filled in the U.S. for the drugs, the majority of which were given Darvocet, which combines propoxyphene with common painkiller acetaminophen.

Doctors are being asked to stop prescribing propoxyphene. Anyone presently taking propoxyphene-containing medications should see their doctor immediately so they can talk about switching to another pain medication.