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This article was originally published in The Tan Sheet

Executive Summary

FDA ADVISORY CMTE. REVIEW OF ASPIRIN SIDE EFFECTS IN ALCOHOLICS could be scheduled for early September, Office of OTC Drug Evaluation Director Michael Weintraub, MD, indicated in July 2 letters to the Nonprescription Drug Manufacturers Association and the Aspirin Foundation of America. In letters seeking assistance from the two groups "in gathering data pertinent to the use of aspirin by alcoholics or heavy drinkers," Weintraub said FDA is "attempting to develop a background package for the [Nonprescription Drugs Advisory Committee's] consideration of this issue in time for its September meeting." The Nonprescription Drugs Advisory Committee voted 9-1 in favor of a warning on acetaminophen products for potential liver toxicity in alcoholics at its June 29 meeting ("The Tan Sheet" July 5, p. 1). However, the committee also asked FDA to delay the implementation of such a warning until the panel could review potential side effects in alcoholics from other OTC analgesic ingredients. During the meeting, Weintraub assured the committee that the agency would bring the issue of potential gastrointestinal bleeding with aspirin and ibuprofen before the advisory committee by the end of 1993 ("The Tan Sheet" July 5, p. 3). The OTC advisory committee is currently scheduled to meet in joint session with the agency's Gastrointestinal Drugs Advisory Committee Sept. 8-9. FDA has set aside one day of the meeting to consider an Rx-to-OTC switch application, presumably SmithKline Beecham's Tagamet ("The Tan Sheet" May 31, p. 1); however, a formal announcement of that meeting has not yet been published. The July 2 letter to the two associations indicates that FDA is not wasting any time nor limiting its review to gastrointestinal side effects. FDA told NDMA and the Aspirin Foundation that it would "appreciate any data you can provide on aspirin or other salicylates and alcohol." "While the incidence of gastrointestinal bleeding in alcoholics and heavy drinkers who use aspirin is of particular interest," FDA noted, "data should not be restricted to this area of concern." Citing the acetaminophen meeting, FDA suggested that other types of data that would be "very useful" include "case reports as well as pharmacokinetic, epidemiologic and animal data, critiques of the data, and similar data for other salicylates." In addition, the agency said it intends "to inform the committee of [FDA's] concerns about the effects of aspirin on blood absorption." FDA noted that the two groups may "want to consider including your comments on the effects of aspirin on blood alcohol levels through its inhibition of gastric dehydrogenase." FDA met with NDMA and the Aspirin Foundation on June 4 to discuss the issue. The Gastrointestinal Drugs Advisory Committee already has experience with the alcohol interaction issue; the committee met to discuss potential interactions between H[2] antagonists and alcohol in March, when the issue of aspirin and blood alcohol levels also was raised ("The Tan Sheet" March 22, p. 4).

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