|DARVON SHOULD BE BANNED|
On January 30, government medical advisers recommended a ban on Darvon, a prescription medicine that's been used to treat pain for more than 50 years.
A Food and Drug Administration advisory panel voted 14-12 to recommend withdrawing Darvon after a daylong hearing examining its risks and benefits. Though the FDA is not required to follow the recommendations of its advisers, it often does so.
Darvon was first approved in 1957. It's now mainly marketed as Darvocet, which includes a dose of acetaminophen. The drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.
Public Citizen, the consumer group, had petitioned the FDA to withdraw Darvon because the drug offers relatively weak pain relief and poses an overdose risk, with the potential to 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 who first sought a ban in the 1970s. "Hopefully the FDA will follow the vote of its advisers."
In an analysis prepared for the hearing, the FDA's safety office said it 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. Most studies show that in Darvocet, the widely used combination drug, the Darvon component appears to contribute "little or no" additional pain relief beyond that provided by the acetaminophen component, reviewers said.
Wolfe presented the advisory panel with new data from the government's Drug Abuse Warning Network, which tracks emergency room visits and deaths. It said that Darvon-related deaths rose to 503 in 2007, from 446 in 2006. In both years, about 20% were suicides.
The United Kingdom banned its version of Darvon in 2005.
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