Cardiovascular disease, including heart disease and stroke, affects tens of millions of people in the United States. Consumers and patients who do not suffer from cardiovascular disease sometimes consider taking aspirin to reduce the possibility of having a heart attack or stroke. Reducing the possibility of having a first heart attack or stroke is called primary prevention. 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. 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 available evidence supports the use of aspirin for preventing another heart attack or stroke in patients who have cardiovascular disease or who have already had a heart attack or stroke. Reducing the risk of additional heart attacks or strokes is known as secondary prevention. In patients who have had a cardiovascular event, the known benefits of aspirin for secondary prevention outweigh the risk of bleeding.
FDA is committed to reviewing any data supporting new medicines and new uses to improve the health of the American public.
Q1. What is primary prevention for cardiovascular disease?
Primary prevention refers to prevention of heart attacks in patients with no prior history of cardiovascular disease.
Q2. What is secondary prevention for cardiovascular disease?
Secondary prevention measures are those measures to prevent further cardiovascular events in patients who have previously experienced a heart attack, stroke or other cardiovascular event to prevent further cardiovascular events.
Q3. Should I stop taking aspirin if my health care provider recommended that I take it to prevent a first heart attack or stroke?
We encourage patients to talk to their healthcare provider about the best treatment for their individual situation. The kinds of evidence FDA uses to make regulatory decisions, which have broad public health implications, may be different from those used by a physician treating a specific patient.
Q4. Has FDA considered additional information/studies about aspirin in reaching this conclusion? Would FDA revisit this decision in the future?
FDA has reviewed studies on the use of aspirin for the prevention of a first cardiovascular event (primary prevention) and did not find sufficient support for the use of aspirin for primary prevention in these trials. FDA is currently awaiting results of additional clinical trials that are underway and are estimated to have reportable results in the next few years. These clinical trials may provide new evidence that could be the basis for changing the current uses (indications) for aspirin.
Q5. Why is FDA issuing this information now?
FDA recently denied a request submitted by Bayer HealthCare, LLC, requesting a change in the prescribing information for health care professionals (professional labeling) for aspirin to allow marketing of the product for prevention of heart attacks in patients with no prior history of cardiovascular disease.
After the 2003 advisory committee meeting, FDA was aware of several ongoing studies for primary prevention in patients with diabetes and diseases of the arteries and veins located outside of the heart and brain (peripheral vascular disease). We opted to wait for the outcome of these studies. The results of these studies were published over the past several years. They did not demonstrate a significant benefit for primary prevention.
Q6. Which other government organizations support the FDA's position?
The Centers for Disease Control and Prevention's (CDC's) national initiative, the Million Hearts Campaign, is focused on increasing appropriate, secondary prevention aspirin use in individuals who already have heart disease or stroke. The CDC, in its Million Hearts Campaign, agrees with FDA's position.
The National Heart, Lung, and Blood Institute (NHLBI) recommends, as does FDA, the use of aspirin for secondary prevention. Specifically, NHLBI recommends using aspirin to lower the risk of a heart attack for those who have already had one, and to keep arteries open in those who have had a previous heart bypass or other artery-opening procedure such as coronary angioplasty.