Aspirin shouldn't be marketed for primary prevention of heart attack or stroke, the FDA has announced. The statement follows the agency's rejection on Friday of Bayer Healthcare's decade-old petition requesting approval of a primary prevention indication. Aspirin is still widely used for primary prevention. The American Heart Association currently supports its use for primary prevention when recommended by a physician in high-risk patients. (There is widespread agreement that for secondary prevention, aspirin's benefits outweigh the risks, and it should be used to prevent a second heart attack or stroke after an earlier cardiovascular event.) In its statement, the FDA said it had "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." Source
