Black Box, Mixed Message? FDA Panel Delivers Acetaminophen Recommendations


If a U.S. Food and Drug Administration expert panel has its way, prescription pain killers, like Vicodin and Percocet that contain acetaminophen will be eliminated from the country's formularies.

Yet, the very same panel voted to keep over-the-counter combination pills containing acetaminophen on the shelves.

Those recommendations are only two of 10 concerning acetaminophen the panel made, including one to lower the maximum dosage of over-the-counter pain medications that contain acetaminophen, like Tylenol.

VIDEO: New Guidelines for Acetaminophen

A joint panel of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee voted on the issues after two days of considering ways to reduce the liver damage risk of acetaminophen, the most commonly used painkiller in the country.

The recommendations are not binding, but the FDA usually adopts them. It's no clear when the FDA will announce a final decision.

The panel voted 24 to 13 against a proposal to remove over-the-counter combination drugs from the shelves. This would save drugs that combine acetaminophen and other drugs like caffeine like Excederin, and a wide variety of popular cough-and-cold combinations.

About 42,000 people visit emergency departments each year with acetaminophen overdoses, half of which are accidental. They often occur when a consumer unknowingly takes more than one acetaminophen product.

Doctors were largely split in their opinions over the votes -- and the fault lines appeared to follow their areas of expertise and the kind of patients they treat.

Liver disease experts largely applauded the recommendations. Dr. William Lee, chair of the liver diseases department at the University of Texas Southwestern Medical Center at Dallas, said he was "highly gratified" by the outcome of the votes limiting acetaminophen use.

Doctors Differ on Acetaminophen Recommendations

"Acetaminophen kills more people annually in the United States than all other prescription drugs combined," Lee said. "That it is [available] over-the-counter, sold in quantities up to 1,000 tablets, and has been advertised for years as being remarkably safe never made sense.

However, some pain management doctors voiced their confusion over the seemingly contradictory recommendations.

"I think that combo products are generally a bad idea -- that is, the idea of giving two or more drugs in fixed ratios," said Dr. Elliot Krane, director of the Pain Management Service at Stanford University's Lucile Packard Children's Hospital.

But he said that he remains baffled as to why the panel would not recommend eliminating acetaminophen from over-the-counter (OTC) combo products as well.

"I'm puzzled by the 'no' vote here, if 10 percent of [overdoses] come from these products," Krane said. "That's a substantial fraction. Why would they not extend the same safety measure to OTC products?"

Other pain physicians noted similar confusion.

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