Bayer, FDA slated to discuss aspirin professional labeling for cardiovascular uses.
This article was originally published in The Tan Sheet
Executive Summary
ASPIRIN FOR CARDIOVASCULAR USE PROFESSIONAL LABELING potential indications will be discussed at an Aug. 28 OTC "feedback" meeting requested by Bayer. Professional labeling currently includes indications for aspirin use for the reduction of death and/or nonfatal myocardial infarction in patients with previous MI or unstable angina pectoris, and for the reduction of the risk of transient ischemic attack (TIA) in men. The current indications are included in FDA's November 1988 tentative final monograph for OTC internal analgesic, antipyretic and antirheumatic drug products. Aspirin is known to help prevent MI by inhibiting prostaglandin synthesis with blood platelets and retarding platelet aggregation.