In what is believed to be the first of many, a wrongful death action against drug manufacturer Xanodyne Pharmaceuticals was recently filed by the family of a man who died due to sudden heart problems after taking the prescription painkillers Darvon and Darvocet.
The active ingredient in Darvon and Darvocet, propoxyphene, was found to lead to a potentially fatal, rapid heartbeat. In November 2010, the U.S. Food & Drug Administration (FDA) asked Xandodyne to remove the dangerous prescription drugs from the market after it determined that Darvon and Darvocet caused QT prolongation, which lengthens the time between electrical impulses that measure the regularity of a heartbeat.
According to the complaint, the man died from sudden heart problems just prior to November's recall. He had been taking the painkillers since July 2010. The lawsuit alleges that Xanodyne failed to warn users about the increased risk of potentially lethal heart rhythm problems.
Darvon was first placed on the market in 1957. According to the watchdog group Public Citizen, which has twice petitioned the FDA to ban propoxyphene, thousands of cardiac toxicity deaths have been linked to the drug since 1981. Fatalities were caused by repeated regular doses, due to a buildup of the drug in one's system, and inadvertent overdoses barely exceeding the recommended dose.
Propoxyphene was banned in the United Kingdom in 2005 and throughout Europe in 2009 for safety reasons, according to Public Citizen. An FDA advisory panel advised the drug be banned in the U.S. in 2009, but it is unclear why the FDA waited over a year to act.