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Xanodyne Pharmaceuticals, maker of the painkillers Darvocet® and Darvon® has pulled both drugs from U.S. market because of potential damage to the heart. The Darvocet® and Darvon® recall was announced Nov. 19, 2010.
Both drugs contain the active ingredient propoxyphene. According the U.S. Food and Drug Administration (FDA), the recall is based on findings that link propoxyphene to fatal cardiac abnormalities and other dangerous heart problems. The FDA is also asking other manufacturing companies to remove the generic versions as well.
The FDA asked the manufacturers to pull propoxyphene-containing painkillers from the market after learning that the medication can affect the electrical activity in the heart, which can result in dangerous arrhythmias.
"These new heart data significantly alter propoxyphene's risk-benefit profile," Dr. John Jenkins, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research (CDER), said in a statement. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."
This is not the first time the FDA has heard of potential health risks associated with propoxyphene. According to the agency, the new scientific data shows that the risks of the drug outweigh its benefits.
To learn more about the Darvocet® and Darvon® recall, contact our drug injury lawyers today.
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