ASPIRIN WARNING TO CONSULT PHYSICIAN PRIOR TO USE FOR HEART ATTACK PREVENTION

ASPIRIN WARNING TO CONSULT PHYSICIAN PRIOR TO USE FOR HEART ATTACK PREVENTION and other "new uses" will soon be proposed by FDA in an upcoming Federal Register notice. The agency proposal would require a warning on aspirin product labeling that cautions consumers to consult with their physicians "before taking this product for your heart or for other new uses of aspirin" because "serious side effects" may occur. An aspirin label warning for "new uses" has been considered by FDA for years. In the November 1988 tentative final monograph for internal analgesic, antipyretic and antirheumatic drugs, FDA suggested that aspirin manufacturers might include a caution in labeling that states: "See your doctor for other uses of [insert name of ingredient or trade name of product], but do not use for more than 10 days without consulting your doctor because serious side effects may occur." The warning was offered due to an FDA concern about consumers self-treating for chronic, professional label indications such as prevention of a second heart attack. FDA underscored in the TFM that "consumers should not self- medicate with an OTC analgesic-antipyretic drug product" for "professional indications" such as: preventing recurrent transient ischemic attacks or stroke in men who have had transient ischemia of the brain due to fibrin platelet emboli; or preventing a second heart attack. However, at an April 1992 hearing of the House Energy & Commerce/health subcommittee, then-Office of OTC Drug Evaluation Acting Director Paula Botstein, MD, reported that the OTC internal analgesics final monograph would not include information about new uses of aspirin related to heart attack and stroke. Because the heart-related uses were not known during the OTC review, Botstein explained, FDA would have to "publish for comment special Federal Register notices and proposals for indications for aspirin" for such uses. The aspirin warning is one of six OTC documents that have recently been cleared for publication by the Office of Management & Budget. The documents are expected to be issued over the next few weeks, pending final review by the Office of OTC Drug Evaluation. Among the upcoming OTC documents are final monographs for OTC pediculicides, OTC digestive aids and OTC skin protectants. TFMs for pediculicides, digestive aids and skin protectants were published in April 1989, January 1988 and February 1983, respectively. Another final rule expected to appear soon will: amend the OTC antitussives final monograph by adding an interaction warning for dextromethorphan-containing antitussives and prescription drugs that contain monoamine oxidase inhibitors; amend the OTC nasal decongestant TFM by revising its MAO inhibitor warning; and revise the MAO inhibitor warning in the OTC bronchodilators final monograph. FDA published the MAO inhibitor revisions for comment in a June 1992 proposed rule. Also slated for imminent publication is a proposed rule addressing alcohol limits for systemic over-the-counter drugs. FDA developed the proposal after its Nonprescription Drugs Advisory Committee, at its inaugural meeting in December 1992, recommended that the alcohol content of OTC systemic medications should not exceed 5%-10% for individuals over 12 years of age and should range from .5% to 5% for children between six and 12 years of age. For children under six, the committee suggested that OTCs be "alcohol free" (.5% or less). The committee's alcohol content limits were similar to those recommended by the Nonprescription Drug Manufacturers Association in a voluntary program for its members on OTC alcohol content.