1 Out of 20 Drug Deaths Related to Darvocet

Propoxyphene has been linked to deaths from heart complications and accidental overdose for more than 30 years, but the FDA delayed requesting market withdrawal of the drug due to “general agreement that additional information about the cardiac effects of propoxyphene would be relevant in further weighing the risk and benefit.” The results of one study provided evidence that even at therapeutic levels, propoxyphene could produce heart rhythm abnormalities. Xanodyne, the company that manufactures Darvon and Darvocet, also indicates that some of the plaintiffs took versions of Darvon Darvocet, arguing that the drug maker could not be held liable in those cases. Both the brand name drugs and their generic equivalents were pulled from the market, resulting in hundreds of Darvocet lawsuits.

Darvocet combines Darvon (propoxyphene) and Tylenol (acetaminophen), and it was one of the most popular painkillers prescribed in the United States before it was recalled. However, the FDA determined that the risk of serious injury or death from Darvocet outweigh any potential benefit it may provide when compared to the use of over-the-counter painkillers. Darvon and Darvocet problems were linked to over 2,110 deaths between 1981 and 1999, accounting for 5.6% of all Darvocet deaths during the time. The FDA, officially, sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious 
or even fatal heart rhythm abnormalities. The decision to recall Darvocet was anounced by the FDA and Xanodyne Pharmaceuticals, Inc. on November 19, 2010.

It has been more than five and a half years since British health authorities cited hundreds of Darvon and Darvocet deaths as the reason they ordered the drug to be phased off of the market, and it has been more than four years since Public Citizen filed their petition urging the FDA to phase the drug out. However, the U.S. drug regulators did not take action to protect consumers from the dangerous Darvocet side effects, and it remained one of the most widely prescribed generic drugs, with approximately 22 million prescriptions in 2007, until November of 2010.