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FDA Advisers Recommend Smaller Doses of Acetaminophen
Date:6/30/2009

The drug can cause liver damage if used improperly

TUESDAY, June 30 (HealthDay News) -- FDA advisers voted Tuesday to recommend that the maximum dose for Tylenol and other pain medications should be reduced to help curb deadly overdoses.

The advisers recommended lowering the maximum dose of over-the-counter acetaminophen -- the key ingredient in Tylenol, Excedrin and other medications.

Part of the problem, according to an FDA report released last month, is that severe liver damage can result from a lack of consumer awareness that acetaminophen can cause such injury. Also, many people may take more than the recommended dose of over-the-counter pain relievers in the mistaken belief that taking more will be more effective against pain without posing health risks. And consumers may not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose.

Despite more than five years of FDA-sponsored consumer education campaigns, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity continue to occur," the report said.

The report also calls for limiting the maximum adult daily dose to no more than 3,250 milligrams, but with a lower daily maximum for patients consuming three or more alcoholic drinks every day while using acetaminophen products. It also recommends limiting the tablet strength for immediate-release formulations to a maximum of 325 milligrams, and the single adult dose to a maximum of 650 milligrams.

The recommendations also include:

  • limiting pediatric liquid formulations to one mid-strength concentration (compared to multiple dose strengths available now);
  • requiring that a measuring device (such as a calibrated cup with dosing increments) be included in each package;
  • including dosing instructions for children under 2 years of age if accurate dosing instructions can be determined and adequate efficacy data exist to support dosing.

On April 28, the FDA said many over-the-counter painkillers and fever reducers will now have to carry new warnings on the potential danger of liver damage and stomach bleeding.

Manufacturers will have to include these warnings on all their over-the-counter products containing acetaminophen, and on all non-steroidal anti-inflammatory drugs (NSAIDs) drugs, the agency said.

NSAIDs include popular medicines such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve) and Excedrin.

The purpose of the new labeling is to raise awareness of potential liver damage from acetaminophen and the potential for stomach bleeding from NSAIDs, the FDA said.

More information

For more on acetaminophen, visit the U.S. National Library of Medicine.



SOURCE: May 28, 2009, news release, U.S. Food and Drug Administration; April 28, 2009, teleconference with Matthew Holman, Ph.D., deputy director, Division of Nonprescription Regulation Development, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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