FDA Advisers Recommend Smaller Doses of Ace...(instructions for children under 2 years ...),Health

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