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An advisory panel to the Food and Drug Administration voted 14 to 12 to recommend the withdrawal of Darvon or Darvocet, a prescription drug that has been used to treat pain for more than 50 years because it has been linked to addiction. The drug is also known by its generic name propoxyphene.
The drug made by Eli Lilly and marketed by Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, was approved in 1957. It was banned in the U.K. in 2005.
The thing is that consumer groups argued that the drug and its derivatives do not offer strong pain relief and thereby pose risks of overdose and potential suicide. Drug makers said it is safe and effective when used as directed. According to the FDA, the drug has been associated with more than 2,000 accidental deaths, is addictive and not safe.
FDA says it found 1,452 deaths associated with propoxyphene from 1957 through September 2008, but some of those reports listed more than one drug. Two of the generics makers selling the propoxyphene products (Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals) say they're safe and effective when used as directed, and they pointed out that more than 600 million scripts for the drugs have been dispensed over the past 50 years.
Dr Sidney Wolfe, a drug safety expert, who had wanted the ban in 1970, lashed out against the drug. He stated that "With a drug that has almost no evidence of benefit, any risk is unacceptable. Hopefully the FDA will follow the vote of its advisers."
Image Credit: www.drugs.com
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