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Review suggests banning Darvon

WASHINGTON — Government medical advisers recommended a ban Friday on Darvon, a prescription medicine that has been used to treat pain for more than 50 years but has left a trail of problems such as addiction and suicide.

A Food and Drug Administration advisory panel voted 14-12 to recommend withdrawing Darvon after a daylong hearing examining its risks and benefits. The FDA is not required to follow the recommendations of its advisers, but often does so.

The consumer group Public Citizen had petitioned the FDA to withdraw Darvon because the drug offers relatively weak pain relief, poses an overdose risk and can be used in suicides.

"With a drug that has almost no evidence of benefit, any risk is unacceptable," said Dr. Sidney Wolfe, a drug safety expert with Public Citizen. "Hopefully the FDA will follow the vote of its advisers."

Two companies that market the drug — Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals— say the medication is safe and effective when used as directed. In documents filed with the FDA, the companies said doctors need a range of options to treat pain, and noted that many other painkillers have become drugs of abuse — some with far worse consequences.

In an analysis prepared for the hearing, the FDA's safety office found more than 3,000 reports of serious problems. The top three were suicide, drug dependence and overdoses.

In a separate analysis, the FDA office that handles painkillers said Darvon is a weak pain reliever.

Data from Florida's medical examiner reporting system showed that in 2007 Darvon was present in the bodies of 341 people who died of any cause. Medical examiners identified it as the cause of death in 85 cases.

Fast facts

About Darvon

1957: Darvon is approved. At the time, there are few alternatives for treating pain except aspirin and powerful narcotics.

2005: United Kingdom bans its version of Darvon.

2007: More than 20 million Darvon prescriptions are written. Mainly marketed as Darvocet, which includes a dose of acetaminophen, the drug remains one of the top 25 most commonly prescribed medications.

Review suggests banning Darvon 01/30/09 [Last modified: Friday, January 30, 2009 9:30pm]
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