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ACETAMINOPHEN/ALCOHOL LABEL WARNINGS WILL BE SUBJECT OF OTC ADVISORY CMTE.

This article was originally published in The Tan Sheet

Executive Summary

ACETAMINOPHEN/ALCOHOL LABEL WARNINGS WILL BE SUBJECT OF OTC ADVISORY CMTE. meeting scheduled for June 28-29. The agency told Whitehall and McNeil in May 6 letters that the committee on June 29 "will discuss the relationship between alcohol and acetaminophen-induced liver toxicity and whether the totality of the information warrants label revisions concerning the use of OTC dosages of acetaminophen with alcohol." Both McNeil and Whitehall have made submissions to FDA on the topic. FDA apprised the firms that recommendations made by the advisory committee would be considered by FDA in "making a final decision on the need for revised labeling concerning use of the acetaminophen-containing OTC analgesic, antipyretic, and antirheumatic drug products with alcohol." Office of OTC Drugs Director-apparent Michael Weintraub noted at the advisory committee's inaugural session in December that FDA was in the process of "rewriting the rulings" on the relationship between acetaminophen and alcohol. He added that a large-scale epidemiologic survey would be considered as part of a notice on the concurrent use of acetaminophen and alcohol. Whitehall proposed several label warnings for acetaminophen- containing products in a 1989 submission to the agency. One of the proposed statements cautioned: "Do not drink alcoholic beverages while taking acetaminophen. To do so may increase the chance of liver damage, especially if you drink large amounts of alcoholic beverages regularly." The Whitehall submission had reviewed 75 cases of acetaminophen-induced liver injury in alcohol abusers. The American Home Products subsidiary also proposed warnings for potential kidney damage associated with acetaminophen consumption and for cross-reactivity between aspirin and acetaminophen. In a separate submission, Whitehall elaborated on the need for a change in the maximum daily dose of acetaminophen for alcohol abusers. McNeil's submissions to FDA also concerned a warning on the use of acetaminophen with alcohol. Prior to the June 28-29 meeting, the OTC Drugs Advisory Committee will join forces with FDA's Arthritis Drugs Advisory Committee on June 1-2 to discuss Syntex' Rx-to-OTC switch application for Naprosyn (naproxen) ("The Tan Sheet" May 3, In Brief).
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