July 8, 2009

FDA Evaluates Painkiller Dangers

Stronger warnings are on the way for painkillers Darvon, Darvocet, and their generic cousins. They are allowed to stay on the market for now, despite pressure from a consumer group to ban the medicine.

The Food and Drug Administration's decision is very different from Britain, which banned the drugs several years ago.

British lawmakers pointed out numerous suicides and accidental overdoses. European Union countries are considering a similar move.

The recent U.S. changes apply to drugs made with propoxyphene, the pain-killing ingredient in privately held Xanodyne Pharmaceuticals Inc's Darvon and Darvocet.

Propoxyphene has been on the market since 1957, and doctors consider it a weak pain reliever.

Public Citizen, a consumer watchdog group, petitioned the FDA to ban it. They argued the minimal benefit wasn't worth the risk that they say caused hundreds of deaths every year.

On Tuesday, the FDA ordered a stern boxed warning be placed on the drug's label, and that patients soon start receiving a special pamphlet with every bottle that stresses the risk of taking too much.

"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.

As for Darvon and Darvocet, Public Citizen is considering whether to appeal FDA's decision or to sue over it.

"This is a reckless decision on the part of the FDA unless they believe Americans are resistant to the death-causing properties of this drug in a way that Europeans and people in the U.K. aren't," said Public Citizen's Dr. Sidney Wolfe.

"You've got a drug which has a barely perceptible benefit and a very clear risk."

A large enough dose of many pain relievers can kill, making it hard to use medication regulation to guard against suicide.

The FDA says about 21 million prescriptions were written for propoxyphene-containing drugs in 2007.

Most popular is Darvocet or its generic equivalent, which combines the narcotic propoxyphene with the more common painkiller acetaminophen.

Wolfe cited data from the government's Drug Abuse Warning Network, which tracks emergency room visits, that counted 503 Darvon-related deaths in 2007, about 20 percent of them classified as suicides.

The agency will further evaluate the safety of propoxyphene and take additional action if necessary, FDA officials said.

The FDA ordered 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.


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