FDA Slaps Strong Warning on Darvon, Darvocet

WASHINGTON, July 8, 2009— -- The U.S. Food and Drug Administration has called for a boxed warning of overdose risk on packages of Darvon, Darvocet and other painkillers containing the drug propoxyphene -- but it will not order their withdrawal from the market.

The agency ordered manufacturers to study higher-than-expected fatality rates in propoxyphene overdoses compared with other painkillers -- and possible toxic effects on the heart in when consumers exceed recommended doses.

However, the FDA rejected a petition from the consumer group Public Citizen calling for phased withdrawal of these products.

In its action, announced during a press briefing on Tuesday, the agency rejected the advice of its own advisory panel, which voted 14-12 for a ban on propoxyphene products because of overdose risk and doubts about their painkilling effectiveness.

Propoxyphene is an opioid painkiller chemically similar to methadone. Some pain specialists, such as Dr. Lloyd Saberski of the Yale-New Haven Hospital in Connecticut, criticize propoxyphene as a weak narcotic with no place on the shelf.

"There is no legitimate medical advantage to keeping propoxyphene available," Saberski said. "You are much better off using small amounts of a potent narcotic; there will be little in the way of side effects."

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, defended propoxyphene as an effective combination treatment option that goes beyond the strength of acetaminophen -- commonly known by the brand name Tylenol -- alone.

"All current pharmacologic options for pain have significant liability," she said in a media briefing. "Given the data currently available to FDA, propoxyphene is an acceptable choice for the treatment of mild to moderate pain when it's taken as directed."

Today's announcement comes just a week after an FDA advisory panel recommended a black box warning for prescription products containing acetaminophen. That panel also voted by a narrow margin to recommend that the FDA pull prescription acetaminophen-containing analgesics from the market.