FDA: no aspirin for primary prevention of myocardial infarction and stroke

The American Food and Drug Administration (FDA) has announced that aspirin should not be used for primary prevention of a heart attack or stroke. The FDA has reviewed the available data and concludes that the evidence does not supports its use as primary prevention. Serious risks are associated with the use of aspirin, such as increased risk of gastrointestinal and intracranial bleeding, in situations in which the benefit of aspirin for primary prevention has not been established.

The use of aspirin for secondary prevention in patients with cardiovascular disease and people who have already experienced myocardial infarction or stroke is, however, supported by the available evidence. In these patients, the benefits of aspirin outweigh the risk of bleeding.

The FDA will continue to review results of ongoing clinical trials. FDA issues the current information now, because it recently denied a request submitted by BAYER HealthCare, to approve a primary prevention indication for aspirin. The FDA had awaited the publication of results of recent clinical studies evaluating aspirin as primary prevention in patients with diabetes and peripheral vascular disease, which did not demonstrate a significant benefit for primary prevention.
FDA Consumer Information 02 May 2014