FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
T98-76                           Susan M. Cruzan:    301-827-6242
October 21, l998                 
                                 Consumer Inquiries: 800-532-4440

FDA APPROVES NEW PRESCRIBED USES FOR ASPIRIN

The Food and Drug Administration today announced a new final rule that substantially expands the recommended prescribed uses of aspirin for patients with cardiovascular and cerebrovascular problems. The rule, which is on display in the Federal Register, also provides information for its use in treatment of rheumatologic conditions.

Under the rule, doctors and health care professionals will be provided with full prescribing information about the use of aspirin in both men and women who have had a heart attack, stroke and certain other cardiovascular conditions as well as rheumatological diseases. For stroke and cardiovascular conditions, lower doses are recommended than those previously prescribed by physicians in practice. Information on the use of aspirin for rheumatologic disease has also been expanded to include specific dosing information as well as information about side effects and toxicity.

The rule updates the professional labeling of over-the-counter aspirin, buffered aspirin, and aspirin in combination with antacid that had been proposed by the agency in 1988 and 1996. The new labeling is based on FDA's evaluation of multiple studies, both here and abroad, on the use of aspirin to treat cardiovascular, cerebrovascular, and rheumatologic conditions.

The rule, which provides labeling to help guide health care providers, does not recommend or suggest the use of aspirin by healthy individuals to lower their risk of heart attack. The final rule also concludes that there are insufficient data to recommend the use of aspirin in patients with peripheral vascular disease, such as those experiencing intense leg pain due to blockage of blood flow to that area of the body.

The following are highlights of the updated professional labeling:

The product is recommended for use in both men and women to treat transient ischemic attack (TIA), ischemic stroke, angina, acute myocardial infarction (MI), recurrent MI, specific revascularization procedures, and rheumatologic diseases.

To minimize adverse events, low dosages (50-325mg) are recommended for cardiac and cerebral vascular uses. (75-325mg are recommended for angina and previous heart attack.)

Aspirin manufacturers who wish to disseminate labeling on the professional uses of aspirin must use the labeling specified in the final rule. The new labeling, which goes into effect in a year, will be provided directly to practitioners licensed to prescribe drugs.

The agency has determined that the advice and supervision of a health care provider is required for these professional uses. Patients should be careful to ask their doctor or health care professional before deciding whether aspirin is right for them and how much aspirin they should take.

For more information on this subject, see "FDA Issues Professional Labeling for Aspirin" on the Center for Drug Evaluation and Research Website.

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