The prescription painkiller Darvon® has been removed from the market by its manufacturer Kentucky-based Xanodyne Pharmaceuticals. The action was taken at the request of the Food and Drug Administration (FDA).

The drug's active ingredient is propoxyphene, which also is used in combination with acetaminophen in Darvocet®.

New Data Show Harm Outweighs Benefits

New studies have shown that propoxyphene can cause serious, sometimes fatal, heart rhythm abnormalities, the FDA said.

"These new heart data significantly alter propoxyphene's risk-benefit profile," said Dr. John Jenkins of the FDA's Center for Drug Evaluation and Research. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," he said.

Dr. Sidney Wolfe, of the Public Citizen's Health Research Group, said the move was too little too late. Britain banned the drug six years ago, he said.

"Our February 2006 petition to the FDA to ban the drug, following the U.K. ban announcement did not even result in an FDA advisory committee hearing until we had sued the agency in 2008 to force them to respond to our petition," Dr. Wolfe said.

FDA Has Split Decision

In response to the citizen's group petition, an FDA advisory committee met in January 2009 to discuss the efficacy and safety of propoxyphene. The committee voted 14 to 12 to withdraw the drug from the market, but noted that more information about the cardiac effects of propoxyphene should be gathered. The agency said it recognized unanswered questions about the drug's safety remained, in particular its effects on the heart.

In July 2009 the FDA announced it was continuing a safety review of the medicine and required Xanodyne Pharmaceuticals to conduct further studies on the drug's safety effects on the heart. The results showed the drug produced significant changes in the heart's electrical activity, causing abnormal and potentially very serious heart rhythm abnormalities.

Who Is Most Susceptible to Darvon®'s Harmful Effects?

Some patients taking the drug are more at risk for heart problems. These include:

• Patients with impaired kidney function
• Patients taking other medications that can affect the heart
• Patients taking medications that can affect the metabolism, or breakdown, of propoxyphene.

Side Effects from Stopping Darvon®

People should speak with their doctors before stopping the medication. Withdrawal can have the following side effects:

• Nausea
• Vomiting
• Diarrhea
• Anxiety
• Shivering

Dr. Wolfe said that "due to FDA negligence, at least 1,000 to 2,000 or more people in the United States have died from using propoxyphene since the time the U.K. ban was announced."

If you or someone you love has taken Darvon and had serious heart problems or died, you should contact a lawyer from Gacovino Lake & Associates to evaluate your prospects for recovering damages for the pain and suffering you have endured. A Gacovino Lake attorney has extensive experience representing clients who have been harmed by drugs and recovered significant rewards for these persons. Contact a Darvon® lawyer today.

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