U.S. orders stronger overdose warning on painkillers

WASHINGTON (Reuters), Jul 7 - U.S. regulators on Tuesday ordered stronger warnings about overdoses with the painkilling drugs Darvon and Darvocet and rejected a call by consumer group Public Citizen for a ban of the medicines.

The action applies to drugs made with propoxyphene, the pain-killing ingredient in privately held Xanodyne Pharmaceuticals Inc.'s Darvon and Darvocet and generic medicines.

Propoxyphene has been on the market since 1957.

The Food and Drug Administration said it was requiring tougher, boxed warnings on the medicines because of reports of accidental and intentional overdoses, including some that were fatal.

"FDA is taking action to reduce the likelihood of such fatal overdoses in the United States while we investigate the safety of propoxyphene more fully," an agency statement said.

"In Europe, there is recent evidence that this medication may be more lethal in overdose than other pain medications," the FDA said.

The agency will further evaluate the safety of propoxyphene and take additional action if necessary, FDA officials said. The FDA is requiring a new study to evaluate the drug's effects on the heart at higher-than-recommended doses.

A Xanodyne official could not immediately be reached for comment.

Public Citizen had petitioned the FDA to order a phased withdrawal of propoxyphene, and an agency advisory panel voted 14-12 in favor of pulling the drugs from the market.

The FDA said it rejected a ban because "the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time."

Last Updated: 2009-07-07 16:48:36 -0400 (Reuters Health)

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