Aspirin: FDA Says 'No'
Written by Editor   
Wednesday, May 07, 2014 12:00 AM

The FDA recently issued a message to consumers stating that the evidence does not support the "general" use of aspirin for the primary prevention of heart attacks and strokes.

"In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain, in situations where the benefit of aspirin for primary prevention has not been established," the agency said, adding that the benefits of aspirin outweigh the risks in the setting of secondary prevention.

The message came shortly after the FDA denied a request from Bayer to change aspirin's label to reflect an indication for primary prevention.

However, the American Heart Association recommends using aspirin for primary prevention in patients with an elevated risk for coronary disease.  And the U.S. Preventive Services Task Force recommends aspirin use for primary prevention in men ages 45 to 79 when the expected reduction in the risk of myocardial infarction outweighs the potential harm of gastrointestinal bleeding and in women ages 55 to 79 when the expected reduction in the risk of stroke outweighs the potential harm of GI bleeding. But it is not recommended in younger patients, and the task force found insufficient evidence to make a recommendation in those 80 and older.