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In Brief: Alcohol warnings on analgesics

This article was originally published in The Tan Sheet

Executive Summary

Alcohol warnings on analgesics: "Each of the currently marketed OTC analgesic/antipyretic drug products may potentiate health risks" among individuals with history of heavy alcohol use or abuse, says FDA Division of OTC Drug Products Director Debra Bowen, MD, in Sept. 23 letter to Thomas Bryant, MD, president of Aspirin Foundation of America, responding to comments on the proposal ("The Tan Sheet" Aug. 19, p. 8). Yet-to-be-published proposed rule requiring warning "is not based on a desire for uniformity in the labeling" of OTC drugs, but rather on concern that warnings only on selective products may lead alcohol users "to conclude that a particular OTC analgesic is safer for their use," Bowen explains...

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