FDA: Aspirin Not For Primary Stroke Prevention

Aspirin should not be marketed for the primary prevention of heart attack or stroke, according to a statement issued by the FDA. 

While there is evidence to suggest that the use of aspirin can prevent secondary heart attacks or stroke in patients with cardiovascular disease, the FDA could not find sufficient backing for its use to prevent a first event.

The statement comes shortly after an FDA decision to deny a Bayer HealthCare request to change prescribing information for aspirin, which would have allowed the product to be marketed for the primary prevention of heart attack and stroke in patients with no history of cardiovascular disease.  
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Originally filed in 2003, the request was put on hold by the FDA to await the results of several ongoing studies of primary prevention in patients with diabetes and peripheral vascular disease.

Using the results from these and other trials, the FDA determined that there was a lack of evidence supporting aspirin use for primary prevention. They warned that the possible benefits did not outweigh the “serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain."

The organization urged patients to consult their healthcare provider before halting aspirin use, because “the kinds of evidence FDA uses to make regulatory decisions, which have broad public health implications, may be different from those used by a physician treating a specific patient.”

"Although we strongly endorse the use of aspirin for secondary prevention, we conclude that there are currently insufficient data to support inclusion of primary prevention of [heart attack] as an indication in the professional labeling of aspirin. We anticipate completion of additional clinical trials currently in progress designed to further investigate the potential role of aspirin for various primary prevention indications," they concluded.

– Michael Potts

References:

Use of aspirin for primary prevention of heart attack and stroke [press release]. US Food and Drug Administration: May 2, 2014. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm390574.htm

US Food and Drug Administration. Citizen's Petition Denial Response [letter]. Docket No. FDA-1977-N-0018-2404; Rockville, MD: May 2, 2014.