FDA Warns Aspirin a Day Not Safe for Everyone

The U.S. Food and Drug Administration (FDA) issued a consumer update today cautioning that while a daily aspirin regimen can help prevent heart attack and stroke in people who have previously suffered these health events, it offers no preventative benefit in people without such medical history.

People may have heard or read about the benefits of aspirin in preventing heart attacks and strokes. Because aspirin is readily available over the counter without a prescription, people may take it without first evaluating their cardiovascular disease risk factors with their doctor or knowing that aspiring use carries a dangerous risk of bleeding.

Aspirin works by interfering with blood’s ability to clot.

“Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence,” said Robert Temple, M.D., deputy director for clinical science at the FDA.

Daily aspirin regimen in these patients is known as “secondary prevention.”

“However, after carefully examining scientific data from major studies, FDA has concluded that the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called “primary prevention.” In such people, the benefit has not been established but risks—such as dangerous bleeding into the brain or stomach—are still present,” the FDA said.

According to the FDA, there is also no evidence that aspirin has any preventative benefit for people with arterial disease or a family history of heart problems or stroke.

Because aspirin affects blood clotting, people who take blood thinners such as warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis) should consult their physician about taking aspirin.

The FDA will continue to monitor ongoing, large-scale clinical studies of aspirin.

The agency made the announcement just days after rejecting a petition by Bayer HealthCare LLC to change the product labeling of aspirin to include the use of 75mg to 325mg aspirin for the primary prevention of a heart attack. The FDA reviewed results of six clinical trials and found no evidence to support that claim; instead finding patients suffered increased incidences of bleeding. The FDA reaffirmed support for aspirin use for secondary prevention.

The American Heart Association (AHA) currently supports the use of aspirin for primary prevention in patients without a history of heart attack or stroke, but whose physician has determined the benefits outweigh the risks.

People should speak with their physician before beginning an aspirin regimen to determine if the benefits outweigh the bleeding risks. A physician can advise the proper dosage and frequency needed to achieve desired results while reducing risk of side effects.

Finally, not all aspirin is the same. Read the aspirin label or ask for assistance from the pharmacist to ensure you are choosing the correct aspirin product.