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Darvon & Darvocet Recalled by Manufacturer

After more than 50 years on the market, popular pain relievers Darvon and Darvocet -- as well as their generic counterpart, known as propoxyphene -- have been recalled after the Food and Drug Administration requested that the painkillers be pulled from the U.S. marketplace. The agency's decision was based on data that showed a risk of serious heart rhythm abnormalities in patients taking the medications. While warning of withdrawal from the drug, the FDA has strongly advised that doctors stop prescribing it to patients immediately. But many say the FDA's actions against the drug have come too late -- decades after the emergence of dangerous side effects and serious health risks. Public Citizen's Health Research Group, a non-profit watchdog organization, has been trying to get the drug recalled for three decades. Most recently, Public Citizen petitioned the FDA in 2006 to ban the medications. Reports of propoxyphene causing heart toxicity have been available from an animal study conducted 30 years ago, according to Sidney Wolfe from Public Citizen. Wolfe says at least 1,000 people in the U.S. have died from using propoxyphene since the 2005 ban in Britain. Wolfe criticized the agency's inaction and called it "a serious indictment of the FDA's long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller." Public Citizen filed a lawsuit against the FDA in 2008 regarding the safety risks of propoxyphene, and has called for a congressional hearing to find out why the agency took so long to take action. Although the FDA is being criticized by groups like Public Citizen, the propoxyphene recall is the second pushed by the agency in the last two months and comes on the heels of a record year for drug recalls. In addition to heart toxicity, Darvon and Darvocet have been linked to other serious side effects such as addiction, overdose, seizures and suicide. Since 1981, Darvocet and Darvon side effects have been found present in over 10,000 confirmed deaths and nearly 2,200 reported accidental deaths.

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