FDA Denies Aspirin Label Change for First MI Prevention

FDA Denies Aspirin Label Change for First MI Prevention
FDA Denies Aspirin Label Change for First MI Prevention

The Food and Drug Administration (FDA) has denied a request for the professional labeling of aspirin to include its use for the primary prevention of a first myocardial infarction (MI) in patients with a chronic heart disease (CHD) risk of ≥10% for over 10 years or positive benefit-risk as determined by a healthcare provider.

The citizen petition was first submitted by Bayer HealthCare in 2003. Aspirin is indicated to reduce combined risk of death and nonfatal stroke after ischemic stroke or TIA, to reduce risk of vascular mortality in suspected acute MI, to reduce combined risk of death and nonfatal MI after MI or unstable angina pectoris, to reduce combined risk of MI and sudden death in chronic stable angina, and for revascularization procedures.

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Data from 6 clinical trials on the role of aspirin in preventing cardiovascular events, including MI, was submitted in the request. The FDA did not find statistically significant results in each of the studies and the trials lacked similar design and a common primary endpoint. In the secondary endpoint analysis, it was suggested that aspirin may reduce nonfatal MI but was not associated with improved mortality. Research on the use of aspirin in higher risk patients, such as those with diabetes, also failed to show aspirin's effectiveness on primary prevention of cardiovascular events.

The decision does not impact the FDA's prior approval of aspirin for secondary prevention of cardiovascular events. Five studies are currently being conducted to continue to evaluate the role of aspirin on cardiovascular event prevention.

For more information visit Regulations.gov.

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