Bayer, FDA slated to discuss aspirin professional labeling for cardiovascular uses.

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.

The scheduled company speaker at the feedback meeting is Bayer Medical & Clinical Affairs Director Steven Weisman, PhD. Representatives from the American Heart Association, the National Stroke Association and the American College of Chest Physicians also are scheduled to attend.

Several other cardiovascular indications for professional labeling have been proposed recently. An indication for aspirin use in patients with suspected MI was proposed by FDA in the June 13, 1996 Federal Register ("The Tan Sheet" June 17, 1996, p. 3). As proposed, the indication would be for reduction of "the risk of vascular mortality in people with suspected acute myocardial infarction."

At a Jan. 23 joint meeting of FDA's Nonprescription Drugs and Cardiovascular & Renal Drugs Advisory Committees, professional labeling was suggested for aspirin use for treatment of stable angina pectoris, prevention of recurrent vascular events, including MI and stroke, and use in people who have had revascularization (bypass surgery) for symptomatic heart disease ("The Tan Sheet" Jan. 27, p. 1).

Tylenol (acetaminophen) marketer McNeil recently submitted comments to FDA suggesting that professional labeling contain a warning directing patients taking aspirin for cardiovascular benefit to consult a physician before using aspirin for analgesic/antipyretic indications ("The Tan Sheet" April 28, p. 13). McNeil argued that such a warning should specify aspirin-related adverse events such as nausea, pain, vomiting and bleeding.

In response to McNeil's comments, Bayer argued that a warning to consult a health care practitioner prior to taking aspirin is "unnecessary" because the analgesic/antipyretic use of aspirin in addition to its cardiovascular use is "short term and not to exceed the current OTC monograph dose limits" ("The Tan Sheet" June 2, p. 7). The proposed warning also could be a topic at the meeting.