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FDA Warns of Low-Dose Use of Aspirin

The U.S. Food and Drug Administration (FDA) has announced that low-dose aspirin should not be marketed to prevent a first heart attack or stroke in patients with no history of cardiovascular disease.

The alert was issued after Bayer Corporation, the manufacturer of the most widely sold brand of aspirin, filed a petition with the FDA to include in its literature accompanying the drug recommendations that aspirin be used as a primary prevention of heart attack and stroke.

After reviewing a number of studies, convincing data showed there was little evidence of any benefit that the use of aspirin prevents heart attack or stroke in both men and women who have never had one before.  In a statement issued by the FDA, it declared that “there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain.” The FDA concluded that the risk of bleeding substantially outweighs the scientifically demonstrated benefit of taking the drug each day.

The American Heart Association and FDA endorse the use of aspirin for patients who are at a high-risk of heart attack or stroke and patients who have survived a heart attack or stroke.  However, the agencies raise concerns about the strategic marketing efforts of aspirin manufacturers.  Dr. Richard Stein, spokesperson for the American Heart Association and professor of medicine and cardiology at NYU School of Medicine, warns of Bayer’s heavy marketing tactics, “Anyone can walk into a drugstore and see a bottle of Bayer’s aspirin with a heart on it.  But there’s no evidence that giving it to low-risk people will lower the heart attack rate.”  He adds, “The worry is that people are starting to put aspirin in the world of vitamins, that if you’re worried about your heart, you should just take it every day.”

The FDA announced that patients should take extensive care when using aspirin with other blood thinners, such as warfarin, dabigatran (Pradaxa®), rivaroxaban (Xarelto®), and apixban (Eliquis®). The FDA advises patients with asthma and uncontrolled high blood pressure not to take aspirin.


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