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.”

FDA consumer information