May 05, 2014
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FDA advises against aspirin for primary prevention of MI, stroke

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The FDA issued a public health advisory announcing that a review of evidence shows no support for the general use of aspirin for primary prevention of MI or stroke.

In addition, the agency informed Bayer HealthCare that it has rejected the firm’s citizen petition requesting an amendment of the rule on professional labeling for aspirin, which would have allowed marketing of aspirin for the prevention of MI in people with no history of CVD. If approved, the amendment would have stated that 75 mg to 325 mg of aspirin daily is appropriate for primary prevention of a first MI among patients with a 10-year risk for CHD ≥10% or a positive benefit-risk ratio as assessed by a health care provider.

“The FDA has reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke,” the agency wrote in the public health advisory. “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 noted in the advisory that aspirin is appropriate for secondary prevention of MI or stroke because the benefits outweigh the risks for bleeding.

The agency stated that if a patient has already been advised to take aspirin for primary prevention of MI or stroke, a discussion with their health care provider about the best treatment for their situation should occur.

In the letter to Bayer, the FDA noted that it had reviewed the results of six clinical trials of aspirin for primary prevention of CV events and their pooled analyses, and that none of the trials achieved statistical significance in their primary endpoints, while all found that participants assigned aspirin had higher rates of bleeding than those assigned placebo. The agency also stated that published studies of aspirin in patients with diabetes or peripheral vascular diseases but no other CV symptoms did not support the use of aspirin for primary prevention of CV events.