Vicodin and Percocet Should Be Banned, FDA Told

Popular prescription painkillers such as Vicodin and Percocet, which combine acetaminophen with stronger narcotics, should be banned because they may cause deadly accidental overdoses, a Food and Drug Administration advisory panel said today.

The panel of physicians and medical experts, meeting this week to discuss ways to curb accidental overdoses and liver damage caused by acetaminophen products, voted 20-17 in favor of pulling the combination drugs from the market.

Citing statistics showing that 60 percent of acetaminophen-related deaths are caused by prescription products as opposed to over-the-counter medications such as Tylenol and Excedrin, the panel urged the FDA to take a tough stance against the products. Acetaminophen remains one of the most commonly taken drugs but also is a leading cause of liver failure in the United States.

There were about 200 million prescriptions written for acetaminophen combination drugs last year, according to the FDA. Vicodin is made by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. There also are less-expensive, generic versions of both painkillers available.

Combination Drugs Can Be Risky

Of particular concern to the panel are patients who take prescription acetaminophen products along with over-the-counter painkillers, which can easily lead to deadly overdoses or severe injury.

“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, according to an Associated Press report.

Still, the vote to ban Vicodin, Percoset and similar pain killers was controversial. Not all panelists supported a ban on drugs that are used to treat 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.

Stern Warnings Should be Added

If the drugs are allowed to remain on the market, panelists overwhelmingly supported – by a vote of 36-1 – to require them to carry prominent “black box” warnings on the labeling to warn users and physicians of the risk of liver failure.

The FDA is not required to follow the advice of its panels, but it usually does. A final ruling on how the FDA will proceed with Vicodin, Percoset, and similar drugs could be made in the coming weeks.

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