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Ketoprofen additional labeling for G-I problems, elderly deemed unnecessary.

This article was originally published in The Tan Sheet

Executive Summary

KETOPROFEN ADDITIONAL LABELING FOR G-I PROBLEMS DEEMED UNNECESSARY by FDA's Nonprescription Drugs and Arthritis Advisory Committees at a July 14 joint meeting. Following a discussion of whether ketoprofen should bear warnings on potential gastrointestinal problems, the advisory committees agreed unanimously that standard labeling for the analgesic class of drugs sufficiently addresses potential problems associated with ketoprofen in both the general population and the elderly. The committees recommended ketoprofen for approval as an over-the-counter analgesic ("The Tan Sheet" July 17, p. 1).

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