OTC ASPIRIN LABELING MAY REFER CONSUMERS TO DOCTORS FOR ADDITIONAL USES IF ACCOMPANIED BY 10-DAY USE WARNING, ANALGESIC-ANTIPYRETIC TFM SAYS
Consumer labeling for OTC aspirin may refer to additional uses for aspirin under a doctor's direction, but only if the reference is accompanied by a warning against extended unsupervised self-medication, according to FDA's tentative final monograph for internal analgesic, antipyretic and antirheumatic drug products. Under the TFM, published in the Nov. 16 Federal Register, appropriate aspirin products have the option of carrying the label statement: "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 TFM requires that all aspirin products carry a warning against use beyond ten days. The placement of an additional caution next to a reference to other uses is intended to prevent self-treatment for chronic, professional label indications such as prevention of a second heart attack. FDA noted that it is proposing the reference to professional claims because of concern that publicity generated about the additional uses may cause consumers to self-medicate. "The agency is concerned that consumers may read or hear this information and self-medicate with an OTC drug product for one of these conditions without consulting with their doctor," FDA said. "Consumers should not self-medicate with an OTC analgesic-antipyretic drug product for any of these professional indications, and use for any of these conditions should be only under a doctor's supervision because serious side effects may occur." The TFM notes that the proposed statement "should be provided to consumers in the most effective manner and should be prominently displayed in labeling so that it may readily be seen and understood." FDA is specifically asking for comments on the proposed statement, its placement in labeling and "whether the 10-day limitation should be an integral part of the required labeling for these products." Professional indications allowed under the TFM include: "Reducing the risk of recurrent transient ischemic attacks (TIAs) or stroke in men who have had transient ischemia of the brain due to fibrin platelet emboli"; and "To reduce the risk of death and/or non-fatal myocardial infarction in patients with a previous infarction or unstable angina." The TFM does not address the use of aspirin in reducing the risk of an initial heart attack. A Nov. 17 FDA "Talk Paper" on the TFM notes that the agency is just now receiving complete data from the Physician's Health Study on use of aspirin to prevent first heart attacks. FDA had previously said that it hoped to reach a decision about the indication on the basis of preliminary results from the trial ("The Pink Sheet" March 7, pp. 3-4). The TFM notes that aspirin products for the TIA indication may not be buffered with sodium. Aspirin and aspirin combination products, including highly buffered aspirin for solution as well as buffered aspirin in a solid oral dosage form, may carry the myocardial infarction indication; however, labeling must include a statement about the amount of sodium in the aspirin/antacid combination "and how much this amount of sodium adds to the intake suggested as appropriate for the dietary treatment of essential hypertension," FDA said.
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