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Panel backs Vicodin, Percocet ban
Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.
A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.
The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.
Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.
Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.
"We're here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.
But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.
"To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake," said Dr. Robert Kerns of Yale University.
In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.
The FDA is not required to follow the advice of its panels, though it usually does.
Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals.
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