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This article was originally published in The Tan Sheet

Executive Summary

ASPIRIN WARNING FOR HEART ATTACK PREVENTION AND "OTHER NEW USES" is proposed by FDA in an Oct. 20 Federal Register notice. The agency is requiring that labeling for all over-the-counter products that contain aspirin, buffered aspirin, and aspirin in combination with an antacid state "in a prominent place" the caveat: "IMPORTANT: See your doctor before taking this product for your heart or for other new uses of aspirin, because serious side effects could occur with self-treatment." FDA is soliciting comments by Dec. 20 specifically on whether the introductory word "IMPORTANT" be changed to "WARNING," and whether other words, such as "unlabeled," would be preferable to the word "new" in the label statement. The labeling statement does not apply to aspirin in combination with acetaminophen, a diuretic, or any cough/cold ingredients. FDA explained that the objective of the aspirin warning is to "inform individuals, who may be informed (by the media or advertisements) about other new uses of aspirin products, that such uses are not risk-free, that adverse effects are associated with these uses, and that the safe and effective use of the drug product for new uses requires the advice and supervision of a physician." In addition, the agency said it is concerned that "people may not understand the risks associated with new uses of familiar products, long available without prescription, especially uses that involve lower doses for a long period of time." Aspirin, FDA added, "particularly if used for a long period of time, may cause serious side effects, including bleeding and stroke." FDA first considered labeling for heart-related uses of aspirin in the November 1988 tentative final monograph for internal analgesic, antipyretic and antirheumatic drugs. In the TFM, the agency suggested that aspirin labels might include a warning to: "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." In response to comments, FDA pointed out in the Oct. 20 notice that it deleted the restriction against use for more than 10 days without consulting a physician because it repeated the "language set forth in the standard [aspirin] warning and is, therefore, redundant." Moreover, "such a statement, made in regard to new uses, may be incorrectly interpreted to imply that people can safely take the product for such uses for less than 10 days without consulting a doctor." The agency had also cautioned in the TFM that consumers should not self-medicate for "professional indications" such as: preventing a second heart attack; or preventing recurrent transient ischemic attacks or stroke in men who have had transient ischemia of the brain due to fibrin platelet emboli. Although professional labeling in the TFM also included indications for rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, ankylosing spondylitis, psoriatic arthritis, Reiter's syndrome and fibrositis, "the agency is concerned primarily with the use of aspirin products to reduce the risk of cardiovascular and cerebrovascular events," FDA said in the Oct. 20 proposal. Such use, the agency added, "is more likely to be initiated by otherwise healthy people who are not under a doctor's care." FDA ultimately decided that labeling on new uses of aspirin would not be included as part of the internal analgesics final monograph because, as explained by then-Office of OTC Drug Evaluation Acting Director Paula Botstein, MD, at an April 1992 congressional hearing, heart-related uses were not known during the OTC review, and FDA would therefore have to publish for comment "special Federal Register notices and proposals for indications for aspirin" for new uses. FDA emphasized that the heart attack/new uses warning "be conveyed in product labeling at the earliest possible date," and will be effective 60 days after publication of a final rule. In the meantime, FDA urged manufacturers of aspirin products to "implement this labeling voluntarily as of the date of publication of this proposal." Subject to the possibility that "FDA may change the wording of the labeling statement as a result of comments filed in response to this proposal," the agency assured manufacturers that they will be given "ample time after publication of a final rule to use up any labeling implemented in conformance with this proposal." The warning will eventually be incorporated into the final monograph for OTC internal analgesic, antipyretic, and antirheumatic drug products.

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