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Acetaminophen warnings

This article was originally published in The Tan Sheet

Executive Summary

Current labeling of OTC acetaminophen products is adequate and an additional general allergy warning or one concerning cross-reactivity for aspirin-sensitive patients is not warranted, McNeil Consumer Healthcare states in comments to FDA. The comments are in response to a June 9 submission filed by Whitehall-Robins (marketer of the ibuprofen analgesic Advil) arguing acetaminophen has allergenic potential and should be required to carry warnings (1"The Tan Sheet" July 5, In Brief). In its response, McNeil cites four new studies and a chart showing a lower incidence of allergic adverse events related to acetaminophen use than with ibuprofen, naproxen sodium and other ingredients

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Whitehall-Robins submits data to FDA regarding acetaminophen's allergenic potential in support of the firm's request the analgesic ingredient be required to bear warnings. The Advil maker provides FDA with eight reports published from 1996-1998 on "consumers' acute hypersensitivity reactions, anaphylaxis, urticaria/ angioedema, delayed hypersensitivity and hypotension following exposure to acetaminophen." The firm notes, "These and previously submitted data indicate that acetaminophen can produce significant and clinically relevant allergic reactions in both aspirin sensitive and insensitive consumers." Whitehall previously filed submissions with FDA in 1989, 1993 and 1997 supporting its request. Advil (ibuprofen) bears a warning on the risk of adverse reactions in aspirin-sensitive patients

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