In November 2010, the FDA announced a recall of Darvon and Darvocet after the agency found that propoxyphene-based medications were linked to an increased risk of heart rhythm problems and sudden heart-related death. The recall, however, came too late for some plaintiffs, who have since filed lawsuits alleging their loved ones died after using Darvon or Darvocet.
One such lawsuit was filed by the parents of a 22-year-old who died eight days after she began taking Darvocet for a knee injury suffered while working at an orphanage. According to reports, Kira Nicole Gilbert died of acute cardiac failure with evidence of fluid buildup in her lungs, despite having no previous history of heart conditions. Gilbert's parents filed a wrongful death lawsuit against Xanodyne Pharmaceuticals Inc., the former distributor of Darvon and Darvocet, and Eli Lilly and Co., the company that originally manufactured Darvon and Darvocet.
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Although the FDA requested a recall of Darvon and Darvocet, critics say that recall was decades too late and argue that the risks associated with the drugs were known for many years. In 2005, Britain banned Darvon and Darvocet because of concerns about suicides and accidental overdoses, according to The Enquirer (02/13/11). In 2009, an FDA advisory panel voted 14 to 12 to recommend that Darvon be taken off the market. The FDA, however, rejected those recommendations and asked Xanodyne to conduct a study on the drug's safety.
It was the results of that study that ultimately resulted in the FDA requesting the pain medications be taken off the market.
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