FDA Panel Urging Reduced Acetaminophen Dosing

Panel recommendation in light of hepatic injury, mortality concerns
By Cynthia Haines, MD
HealthDay Reporter

TUESDAY, June 30 (HealthDay News) -- A panel of U.S. health advisors has recommended changes in the dosing and availability of over-the-counter and prescription acetaminophen due to risks of severe liver damage or death. The recommendations follow a report issued by the U.S. Food and Drug Administration (FDA) last month.

The FDA advisory panel voted 21 to 16 in favor of lowering the maximum daily dose of nonprescription acetaminophen, currently set at 4 grams, and voted 24 to 13 in favor of reducing the maximum single dose of acetaminophen to 650 mg from 1000 mg. The panel also voted in favor (26 to 11) of making 1000 mg doses of acetaminophen available by prescription only.

The panel voted against implementing additional safety restrictions for over-the-counter products containing acetaminophen, such as NyQuil or Theraflu, but voted in favor of removing prescription products that combine acetaminophen and an opiate.

"I think the top recommendation of this committee was that the agency needs to do something to address and decrease the usual dose of acetaminophen, both for over-the-counter products and also prescription combination products," Sandra L. Kweder, M.D., deputy director of the FDA's Office of New Drugs at the Center for Drug Evaluation and Research in Silver Spring, Md., said in a press briefing.

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