BMJ 2014;348:g3168 doi: 10.1136/bmj.g3168 (Published 8 May 2014)
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NEWS FDA questions use of aspirin for primary prevention of stroke and heart attack Michael McCarthy Seattle
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.1
“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 added. The agency did, however, endorse the use of aspirin for secondary prevention in patients with known cardiovascular disease or who have had a stroke or heart attack.
The FDA recently denied a request by Bayer HealthCare to change the prescribing information to healthcare professionals to allow the marketing of its aspirin product for the primary prevention of heart attacks.
US physicians often recommend daily aspirin in low doses, 75-100 mg, to asymptomatic adults for the primarily prevention of heart attack and stroke. The American Heart Association recommends daily low dose aspirin for primary prevention in people at high risk of myocardial infarction and ischemic stroke but only after consultation with a healthcare provider, said Richard Stein, a
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cardiologist and professor of medicine at New York University School of Medicine and a spokesman for the association. Taking aspirin for a few days to treat aches and pains is associated with very few adverse event reports, Stein said, “but once you start giving people 81 mg [a commonly available low dose aspirin] a day, every day, you are significantly reducing the activity of their platelets.” This can be very beneficial if you rupture a plaque, he noted, but can also increase the risk of gastrointestinal bleeding, an intracranial hemorrhage, or some other serious hemorrhagic complication.
Although it would be impossible to require a prescription for low dose aspirin, given how long the drug has been available over the counter, Stein said, “my personal feeling is that 81 mg of aspirin taken every day for the rest of your life should be a prescribed drug.” Patients should not be deciding to start low dose aspirin on the basis of a television advertisement, Stein added. “You should really talk to your doctor, who can assess your risk factors and help you make an informed decision.” 1
Food and Drug Administration. Use of aspirin for primary prevention of heart attack and stroke. 2 May 2014. www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm390574.htm.
Cite this as: BMJ 2014;348:g3168 © BMJ Publishing Group Ltd 2014