FDA Pulls Painkiller Darvon Over Safety Risks
November 22nd, 2010
By: Matthew Perrone
The maker of the painkiller Darvon is pulling the drug off the market under pressure from public health officials who say it causes dangerous heart rhythms.
The Food and Drug Administration says the drugmaker Xanodyne will halt marketing of Darvon and related brand Darvocet. The FDA has also called on generic drugmakers to stop marketing low-cost versions of the drug.
The FDA action puts the U.S. in line with Britain, which banned Darvon several years ago due to suicides and accidental overdoses.
Darvon, first approved in the 1950s, is an opioid used to treat mild to moderate pain.
The consumer watchdog group Public Citizen had petitioned the FDA to ban the drug, saying its benefits didn’t justify a risk that added up to several hundred deaths a year.