Painkiller Linked to Deaths Should Be Withdrawn, Fda Panel Says
A joint FDA advisory committee meeting in Gaithersburg, Maryland, today voted 14-12 that the risks of Darvon outweigh its benefits, said Karen Riley, a spokeswoman for the agency, in an e-mail. The prescription medicine, known chemically as propoxyphene, has been sold since 1957 for mild to moderate pain.
The panels recommendation, while not binding on the FDA, is a victory for Public Citizen, a Washington consumer group that petitioned the agency in 2006 to take the painkiller off the market. The group said the drug and its generic equivalents were linked to more than 2,000 accidental deaths in the U.S. from 1981 to 1999. FDA staff disagreed in a report released on Jan. 16, saying the known risks were consistent with product labeling.
“There is little doubt that were propoxyphene and propoxyphene-containing products to come before these committees today for approval, based on what is now known, they would be rejected because of one of the most unfavorable benefit-to-risk ratios ever seen for a drug,” Sidney Wolfe, head of Public Citizens health research group, told the advisory panel today.
The FDA usually follows the recommendations of its advisory panels, though it isnt required to do so. Theres no deadline by which the FDA must decide what action to take.
Closely held Xanodyne Pharmaceuticals Inc. of Newport, Kentucky, markets the Darvon and Darvocet brands and believes they are safe and effective, said Kevin Anderson, the companys chief compliance officer, in an e-mail last month. Darvocet contains acetaminophen, the active ingredient in Johnson & Johnsons Tylenol.