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Propoxyphene
(Darvon and Darvocet)
Heart Attack :: Heart Failure :: Sudden Cardiac Death
Propoxyphene (Darvon and Darvocet) is an opiod painkiller that was first sold as Darvon in 1957. Darvocet is a combination drug made with propoxyphene and acetaminophen. It was originally developed by Eli Lilly & Co., but is now marketed by Xanodyne Pharmaceuticals.
In November 2010, the U.S. Food and Drug Administration (FDA) announced that Xanodyne Pharmaceuticals Inc. had agreed to pull Darvon and Darvocet from the market after a study linked propoxyphene to serious and sometimes fatal heart rhythm problems. The agency also asked makers of generic propoxyphene medications to pull those as well. Propoxyphene (Darvon and Darvocet) may be potentially linked to serious heart problems including, cardia arrest, heart failure, irregular heart rythmns and cardiac death.
It is estimated that 10 million prescriptions were written in 2009.
FDA Review - Propoxyphene (Darvon and Darvocet)
In July 2009, the FDA issued a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. While the new warning did not include mention of heart rhythm problems, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart. Ultimately, that study found that even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart.
Apparently, these changes to the electrical activity of the heart, which can be seen on an electrocardiogram (ECG), may increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. Apparently, the propxyphene metabolite, can lead to irregular heartbeat in the form of QT prolongation, which extends timing between Q and T waves—two of five electrical impulses measuring heartbeat regularity. The FDA also said it was asking the manufacturers of generic propoxyphene-containing products to remove those products from the market.
If you or a loved one has taken Darvocet and experienced heart problems while taking Darvocet, contact us for a free case evaluation, or call our lawyers at 1-800-672-4916.
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