From Reuters:The long-time leading prescription painkiller Darvon and its generic versions have been linked to thousands of deaths and should be taken off the U.S. market, a consumer group told federal health regulators on Tuesday.
In a petition to the U.S. Food and Drug Administration, Public Citizen said the drug propoxyphene, sold by Xanodyne Pharmaceuticals under the brand Darvon, had been linked to 2,110 deaths between 1981 and 1999 -- nearly 6 percent of all drug-related fatalities.
While the drug has been around for decades, last year British health authorities announced a phased withdrawal, and the U.S. advocacy group called on the FDA to follow suit.
FDA spokeswoman Laura Alvey confirmed that the agency received the petition and would review it carefully but could not comment further.
The risks outweigh the minimal benefits of the drug, which may also be addictive and "has repeatedly been shown in controlled clinical trials to be a relatively weak painkiller," Public Citizen wrote.
Twenty-three million propoxyphene-based U.S. prescriptions were filled in 2004, making it the 12th top-selling generic drug with $291 million in sales, according to the petition.
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