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Aspirin:  Do the Benefits Outweigh the Risks?

By J. Douglas Overbeck, M.D.

Aspirin has largely been marketed as a primary prevention to heart disease and stroke, but the Food and Drug Administration has recently released new information for consumers concerning the use of aspirin in regards to heart disease and stroke prevention. Primary prevention, as defined by the FDA, is the prevention of heart attacks in patients without previous coronary artery disease or stroke history; and while cardiovascular disease affects millions of people in the United States, many who have no history of cardiovascular disease are using aspirin to reduce their chances.

It is with those who have no history of cardiovascular disease that the danger comes in. The FDA stated in their Use of Aspirin for Primary Prevention of Heart Attack and Stroke, it “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,” which include “increased risk of bleeding in the stomach and brain, in situations where the benefit of aspirin for primary prevention has not been established.” Put simply, the benefits don’t outweigh the risks.

This statement follows on the heels of a denial response from the FDA to Bayer HealthCare in regards to a citizen petition submitted in February 2003 requesting a primary prevention label indicator. Within the denial, the FDA also reaffirmed their approval of aspirin use for secondary prevention, or measures to a heart attack in those who have already experienced an attack, stroke or other cardiovascular event.

The FDA had ruled in a 1998 that there was insufficient evidence for the indication of aspirin as a primary prevention. However, in 2002 the U.S. Preventative Services Task Force and the American Heart Association published clinical guidelines that recommended the use of aspirin for primary prevention, which Bayer based part of their petition upon.

The FDA rejection response to Bayer concludes, “recent published reports also show that, even in patients considered at higher risk, such as diabetics, the efficacy of aspirin for primary prevention remains unproven…[and they] heartily endorse the use of aspirin for secondary prevention in an appropriate patient population under the direction of a health care provider.”

Although the FDA states that aspirin is no longer a candidate for primary prevention for healthy individuals, studies are still underway to attain more substantial results and information about aspirin use by those with no cardiovascular event history, and the known benefits of aspirin as secondary prevention outweigh the risk of bleeding. If you have questions or concerns about an aspirin regimen as primary or secondary prevention, please contact your health care provider.