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Darvon®, Darvocet®, and its generic equivalents are mild to moderate narcotic prescription painkillers that all contain the active ingredient propoxyphene. It is the only active ingredient in Darvon®. In Darvocet® and its generic counterparts, the main active ingredients are propoxyphene combined with acetaminophen, which enhances the painkilling effect of propoxyphene.

Darvocet® Black Box Warning

On July 7, 2009, the U.S. Food and Drug Administration (FDA) took three major actions to warn patients and physicians about the risk of overdose of propoxyphene-containing medications Darvocet®, Darvon®, and equivalent generic drugs.

The FDA ordered that:

• The drugs’ manufacturers strengthen the label, including a black box warning, about the risk of overdose of the medication. A black box warning is the strongest warning a manufacturer can state about a drug’s safety. It is literally a warning in bold face print surrounded by a black-lined square on its label.
• The drug makers provide a medication guide to patients stressing the importance of following the label’s directions.
• The manufacturers begin a new safety study of the effects of propoxyphene on the heart when taken at higher than recommended doses.

Darvocet® Warning Recall

Since 1978, the FDA has received two requests to withdraw propoxyphene from the market.  Until the drug was recalled, however, its benefits always were deemed to outweigh its risks, reports the agency.

In January 2009, an FDA advisory committee met to review the efficacy and safety of propoxyphene. The committee reviewed the original application for the drug and results of subsequent studies. It voted 14 to 12 to take the medication off the market.

But, in July 2009, the FDA went against its advisory committee’s recommendations and refrained from recalling the drug. The FDA said it believed that the benefits still outweighed the risks. However, it did require the boxed warning about the risk of overdose.

On Nov. 19, 2010, the FDA announced the results of the new safety study indicating that the medications, even when taken at recommended doses, pose a serious threat to patients’ hearts.  Electrocardiograms show the drugs caused dangerous electrical changes in the heart that result in potentially fatal arrhythmias, or abnormal heart rhythms.

Finally, the FDA concluded the benefits no longer outweighed the risks and asked Xanodyne, the manufacturer of Darvon® and Darvocet®, to take its drugs off the market. It also requested that the companies making generic versions of the drug recall their medications as well.

Darvocet® Recall Lawsuits

Millions of people have been prescribed Darvocet® and other propoxyphene drugs. Now that these drugs have been linked to serious and even fatal heart problems, the number of lawsuits against the manufacturers is expected to rise. If you suspect that your heart trouble resulted from taking Darvocet®, our attorneys may be able to help you.

Contact a Darvocet attorney today to schedule a free evaluation of your case.

"Darvocet® and Darvon® Recalled for Fatal Heart Side Effects"

Xanodyne Pharmaceuticals, maker of the painkillers Darvocet® and Darvon® has pulled both drugs from U.S. m...

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