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FDA: Daily Aspirin Risks Outweigh Benefits in People with No History of Prior Heart Attack

May 8, 2014

The U.S. Food and Drug Administration (FDA) just announced that daily aspirin should not be used in people who have never had a heart attack, but who believe they may be at risk.

Based on literature reviewed by the agency, although daily aspirin might be a recommended protocol for people who have had a prior heart attack, for those with no cardiovascular disease history, there is insufficient evidence that the risks are outweighed by any potential benefit, the FDA announced, according to Forbes.

This FDA announcement followed a denial by the FDA to allow Bayer to update its aspirin labeling to indicate aspirin use in the prevention of heart attacks in people with no history of heart disease, wrote Forbes.

“Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a re-occurrence,” said Robert Temple, deputy director for clinical science at the Food and Drug Administration (FDA), in a statement that appears on the FDA website. The FDA also warns that people who are also taking taking prescription blood thinners like warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis), be especially aware of the risks of taking aspirins with these medications, Forbes reported.

Meanwhile, for individuals who have never had a heart attack, even if there is a family history of cardiovascular disease, there is no data that suggests that daily treatment with aspirin will be of benefit sufficient to outweigh associated risks, Forbes reported. In fact, the FDA concluded that existing data simply do not support aspirin use as a form of what the agency described as “primary prevention” in those who have not suffered a prior heart attack or stroke and who do not have vascular problems.

Taking aspirin regularly over a prolonged period may lead to internal bleeding, a risk not outweighed by the drug’s benefits, according to the FDA. In fact, the agency indicated that risks far outweigh any potential benefits, Forbes reported. According to the FDA, “the benefit has not been established but risks—such as dangerous bleeding into the brain or stomach—are still present.” Large-scale studies are underway, and the FDA will be tracking that research to determine if their recommendation may require future change.

The Mayo Clinic does note that stopping an aspirin regimen suddenly when a person has been taking it for some time, may create a so-called “rebound effect,” in which the risk of heart attack increases. Individuals with no history of heart disease and who have not had a heart attack, but who are on an aspirin regimen, are advised to consult with their physician before stopping the treatment, Forbes noted.

"Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke, or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence," Temple says. (A dose ranges from the 80 milligrams (mg) in a low-dose tablet to the 325 mg in a regular strength tablet.) This use is known as "secondary prevention."

“The bottom line,” wrote the FDA, “is that in people who have had a heart attack, stroke or cardiovascular problems, daily aspirin therapy is worth considering. And if you're thinking of using aspirin therapy, you should first talk to your health care professional to get an informed opinion,” Temple says.


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