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Executive Summary

ASPIRIN LABELING: FDA IS EVALUATING ACUTE MYOCARDIAL INFARCTION INDICATION in professional labeling. The aspirin industry is actively seeking the new indication. At a meeting with FDA officials in January, representatives of the Aspirin Foundation of America presented FDA with data from the 1988 ISIS-2 study of suspected acute myocardial infarction patients. The study, which compared the use of aspirin and streptokinase both singly and in combination, reported a significant decrease in vascular deaths with the combination treatment, suggesting that the two drugs' activity is additive. Treatment with the two drugs also avoided the increase in nonfatal reinfarctions that was seen with streptokinase treatment alone. According to an FDA memorandum summarizing the Jan. 6 meeting, the Aspirin Foundation believes the data "support an important new use of aspirin that has minimal side effects." The foundation added that "it is in the public interest to inform physicians of the use of aspirin for the treatment of acute myocardial infarction as quickly as possible." FDA officials "indicated a desire to proceed quickly with their evaluation of the data," the memo noted. The agency cannot complete its review, however, until it has received raw data from the ISIS-2 study. That data was requested in early December but has not yet been received by the agency. The industry reps indicated they would "try to expedite" the data submission. The procedural options for adding the indication to professional labeling include reopening the administrative record for OTC internal analgesic, antipyretic and antirheumatic drug products and amending the tentative final monograph; or publishing the agency's conclusions on the data in a Drug Bulletin article and including the indication in an amendment to the TFM. The discussion touched "briefly" on specifics of a professional labeling indication for acute MI, including dosage and whether an indication should be limited "to plain aspirin," according to the meeting notes. The group also considered presenting the issues to the agency's Cardio-Renal Drug Products Advisory Committee but decided not to do so.

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