FDA PROPOSES NEW WARNINGS FOR OTC PAIN RELIEVERS

Common OTC pain relievers would have to carry prominent new warnings about the potential for stomach bleeding and liver damage under an FDA-proposed rule.

The proposal would amend the labeling regulations on OTC internal analgesic, antipyretic and antirheumatic drugs. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, would be required to include warnings about the potential for stomach bleeding, while acetaminophen would have to include warnings about the potential for liver damage.

The proposed rule would also require that the ingredient acetaminophen be prominently identified on the principal display panel of the immediate container as well as on the outer carton, if applicable. The typeface used would have to be at least one-fourth of the size of the most prominent text on the label.

The warnings for products containing NSAIDs would highlight the potential for stomach bleeding in people who are more than 60 years old, have had ulcers or bleeding, take blood thinners, take more than one product containing an NSAID, take an NSAID with moderate amounts of alcohol or take an NSAID for a longer time than directed. This would be required to be the second warning on aspirin labels and the first on ibuprofen labels.

In the public comments, which must be submitted within 90 days of the scheduled Dec. 26 publication of the proposed rule in the Federal Register, the FDA would also like some discussion of the scientific validity of UK regulations that place a limit on acetaminophen package size.

Public comments can be viewed at www.fda.gov/ohrms/dockets/ac/cder02.htm#NonprescriptionDrugs.