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NSAID petition

This article was originally published in The Tan Sheet

Executive Summary

FDA has not yet reached a decision on a citizen petition asking the agency to research a link between ibuprofen, Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). Seven petitioners had asked FDA in a Feb. 1 filing to conduct an assessment of ibuprofen and SJS/TEN risk, to investigate whether manufacturers withheld safety information related to such risks, and to add warnings to Rx and OTC labeling. The petition "raises complex issues requiring extensive review and analysis," FDA explains in an Aug. 5 response. The agency notes it has already directed manufacturers to make labeling changes to ibuprofen and other NSAIDs to "include additional warnings regarding the risks of SJS and TEN" as requested in the petition (1"The Tan Sheet" June 20, 2005, p. 5)...

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