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Darvocet, an opioid pain killer, was recalled from the market by the Food and Drug Administration and its manufacturer, Xanodyne Pharmaceuticals, in November 2010. The drug was recalled by the United Kingdom six years ago. The European Medicines Agency Committee for Medicinal Products for Human Use recommended the European Union take the drug off the market in June 2009.

2010 FDA Recall

The Food and Drug Administration recalled Darvocet on November 19, 2010, because the medication was causing abnormalities in the electrical activity of the heart, leading to dangerous heart rhythms, heart attacks and death. An FDA advisory committee made the decision after reviewing data gathered from multiple studies showing that one of the medication's active ingredients, propoxyphene, was causing serious these heart rhythm abnormalities.

The two active ingredients in Darvocet are:

• Propoxyphene
• Acetaminophen

Propoxyphene is a narcotic pain reliever used to treat mild to moderate pain. Other names under which the medication is sold are:

• Darvon, in which it is the single active ingredient
• Propacet 100
• Dolene
• Wygesic
• SK-65
• SK-65 APAP
• Trycet
• Genagesic
• E-Lor
• Balacet

The FDA said that a patient taking this drug could suffer these heart problems at any time, regardless of how long he or she had been taking it. The risk of heart difficulties was increased by:

• A change in the person's health
• Decreased kidney function
• Taking certain additional medications

New data from the FDA's most recent study showed the risk of taking propoxyphene outweighed its benefits. A study in 2009, to the contrary, showed the drug was still relatively safe and the benefits outweighed the Darvocet side effects. The decision was reached by a narrow split vote of the agency's advisory committee. The committee had voted 14 to 12 against continuing to market propoxyphene.

Because of ongoing concern about the medication, the FDA required the manufacturer to conduct a safety study of the drug at higher than recommended doses. The FDA said it was making the 2010 announcement because these new data showed more conclusively the drug's danger to the heart.

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

Contact a Darvocet Recall Attorney

If you or someone you love has had serious heart problems or suffered a heart attack while taking Darvocet, you deserve to be compensated for pain and suffering. You should contact a Darvocet lawyer. Your initial consultation is free.

"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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