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FDA questions use of aspirin for primary prevention of stroke and heart attack

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g3168 (Published 08 May 2014) Cite this as: BMJ 2014;348:g3168  Michael McCarthy

Aspirin should not be routinely used for the primary prevention of heart attack or stroke in patients with no history of cardiovascular disease, the US Food and Drug Administration has concluded.

“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,” it said in a statement posted online last week.

“In fact, there are serious risks associated with the use of aspirin.”

The description below provides the text of the statement

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.