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May 6, 2014
08:30 EDTBAYRYFDA says data doesn't support aspirin as defense against first heart attack
The FDA stated in a consumer information communication issued May 2 that it 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 FDA said. The available evidence supports the use of aspirin for preventing another heart attack or stroke in patients who have cardiovascular disease or who have already had a heart attack or stroke, the FDA added, stating that the known benefits of aspirin for secondary prevention outweigh the risk of bleeding in patients who have had a cardiovascular event. “Importantly, the ruling does not impact the numerous cardiovascular indications for which aspirin is already approved by the FDA,” Anne Coiley, a spokeswoman for Bayer, said in an e-mail to Bloomberg. Reference Link
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