Use of Aspirin for Primary Prevention of Heart Attack and Stroke
[05/02/2014] 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 already had a heart attack or stroke, or have other evidence of coronary artery disease, such as angina or a history of a coronary bypass operation or coronary angioplasty. Reducing the risk of additional heart attacks or strokes is known as secondary prevention. In patients who have had such cardiovascular events, 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.
- What is primary prevention for heart attack or stroke?
- What is secondary prevention for heart attack or stroke?
- Should I stop taking aspirin if my health care provider recommended that I take it to prevent a first heart attack or stroke?
- Has FDA considered additional information/studies about aspirin in reaching this conclusion? Would FDA revisit this decision in the future?
- Why is FDA issuing this information now?
- Which other government organizations support the FDA’s position?
Q2. What is secondary prevention for heart attack or stroke?
Secondary prevention refers to measures to prevent another heart attack or stroke in patients who have previously experienced a heart attack, stroke or other cardiovascular event.
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.
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.