FDA nixes use of aspirin for primary prevention

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FDA issued a statement regarding aspirin's use in preventing heart attacks, saying it does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke.

It comes after the agency denied a request from Bayer HealthCare, requesting a change in the prescribing information for HCPs (professional labeling) for aspirin to allow marketing of the product for prevention of heart attacks in patients with no prior history of cardiovascular disease.

The regulator stated yesterday that “after carefully examining scientific data from major studies, FDA has concluded that the data do not support the use of aspirin as a preventive medicine by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called ‘primary prevention.'”

FDA did state, however, that “the available evidence supports the use of aspirin for preventing another heart attack or stroke in patients who have cardiovascular disease or who have already had a heart attack or stoke.”

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