The US Food and Drug Administration set off a firestorm by calling into question a common practice: taking a baby aspirin a day to prevent heart disease. The agency first denied Bayer HealthCare’s request on May 2 to make the claim on its aspirin labels that the drug could be used to prevent a first heart attack in patients deemed by their doctors to be at high-risk of heart disease.
On May 5, the FDA posted a consumer update that said “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.” Side effects — like stomach ulcers and bleeding into the brain or digestive tract — outweigh the benefits even in those with diabetes, a smoking habit, or other heart disease risk factors, the FDA stated.
For those who already had a heart attack, the agency emphasized, the benefits of using aspirin to prevent another one clearly outweigh the risks. That’s something prevention experts can all agree upon — and which is already printed on the aspirin bottle.
But the FDA’s stance on using aspirin for “primary prevention” of a first heart attack runs counter to what other medical groups recommend. A daily low-dose aspirin is recommended by the American Heart Association and the American Diabetes Association for those with diabetes who have other heart disease risk factors.
In 2010, the groups “stepped back from prior recommendations that most people with diabetes should be on aspirin, and instead only recommended it for primary prevention in those at very high risk,” said Dr. M. Sue Kirkman, an endocrinologist at the University of North Carolina School of Medicine who co-authored the guideline. This includes men over age 50 and women over age 60 who have diabetes and at least one other heart risk like high blood pressure.
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