FDA Advises Against Aspirin Use for Primary Prevention of Heart Attack

An FDA report concludes that aspirin’s risks may outweigh its benefits in patients who do not have a history of cardiovascular problems.

Although evidence supports the use of aspirin to prevent a second heart attack or stroke among patients with cardiovascular problems, data indicate that taking the medication daily may do little to prevent a first heart attack or stroke among heart-healthy patients, according to a consumer update published by the FDA. The report, published on the FDA website on May 5, 2014, does not support daily aspirin use for the primary prevention of heart attack or stroke and suggests that patients only begin aspirin therapy after speaking with a health care professional.

After analyzing evidence collected from major studies, the FDA concluded that the risks of daily aspirin use may outweigh the benefits for patients without a history of heart attack, stroke, or cardiovascular problems. Although dangerous side effects, including bleeding into the brain or stomach, have been associated with the medications, the benefit has yet to be established among these patients.

“The bottom line is that in people who have had a heart attack, stroke or cardiovascular problems, daily aspirin therapy is worth considering,” the update suggests. “And if you're thinking of using aspirin therapy, you should first talk to your health care professional to get an informed opinion.”

Patients considering aspirin therapy for secondary prevention should discuss dosing and frequency with a health care professional in order to receive the maximum benefit with the least side effects before taking the medication, the report notes. In addition, the agency suggests that patients already taking blood thinners should take extra care before beginning aspirin therapy.

If patients are recommended to take daily aspirin by a professional, the FDA suggests that patients read product labels carefully to be sure they do not use combination products containing other pain relievers or ingredients that are not intended for long-term aspirin therapy.