(15-05-14) FDA Comes Out Against Aspirin for Primary Prevention

By Larry Husten

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: Link(s):
May 6, 2014
FDA consumer information (Free)

Background: NEJM Journal Watch General Medicine coverage of USPSTF
recommendations on aspirin use (Your NEJM Journal Watch registration
required)
- See more at:
http://www.jwatch.org/fw108799/2014/05/06/fda-comes-out-against-aspirin-prim
ary-prevention?query=pfw#sthash.RMCzXNGi.dpuf

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