Advisory Panel for the FDA Recommends Withdrawal of Darvon
The prescription pain medication Darvon has been under fire for some time concerning its troubling problems such as addiction and suicide. A government medical advisory panel for the U.S. Food and Drug Administration voted 14 to 12 in recommending the withdrawal of the popular pain killer from consumer use after a day long hearing examining its risks and benefits. In 2005 the United Kingdom banned its version of Darvon for the same reasons. Darvon was first approved in 1957, when there were few alternatives for treating pain except aspirin and powerful narcotics. The non-profit consumer group Public Citizen petitioned the FDA for the removal of Darvon, now mainly marketed as Darvocet which contains acetaminophen, after expressing concern over the drug’s relatively weak pain relief and the potential overdose risk.
“With a drug that has almost no evidence of benefit, any risk is unacceptable,” said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first sought a ban in the 1970s. “Hopefully the FDA will follow the vote of its advisers.”The two companies that market the drug, Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, say the medication is safe and effective when used as directed. If the FDA elects to not take the panel’s advice, which is unlikely, further measures such as stiffer warnings, safety studies or special education efforts aimed at doctors and patients may be put in place.
