The Food and Drug Administration (FDA) has refused a request from Bayer HealthCare to change its aspirin labeling to indicate aspirin use for the prevention of heart attacks in people without a history of heart disease.
Though daily aspirin is often recommended for people who have already had a heart attack, the FDA said it’s a different situation for people who have never had a heart attack, according to Forbes. After examining the scientific literature, the FDA feels that there’s not enough evidence that the benefits of aspirin outweigh its risks for people who have no history of cardiovascular disease. “FDA has concluded that the data do not support the use of aspirin as a preventive medication,” according to the consumer update posted Monday on its web site, Can an Aspirin a Day Help Prevent a Heart Attack?
Robert Temple, deputy director for clinical science at the FDA said, “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.” But for people who have never had a heart attack, there are no data to suggest taking daily aspirin will do more good than harm, according to Forbes.
At issue are the side effects – most notably internal bleeding – of taking aspirin regularly over time, Forbes reports. The FDA says that “the benefit has not been established but risks – such as dangerous bleeding into the brain or stomach – are still present.” Large-scale studies of daily aspirin are under way, but in the meantime, the agency does not recommend daily aspirin to prevent a first heart attack and recommends that consumers discuss the issue with a doctor. Those already taking daily aspirin, though, should not stop suddenly. The Mayo Clinic warns that stopping aspirin suddenly after taking it for a while can create a “rebound effect,” actually increasing heart attack risk.
The update reiterates the risks of taking aspirin when also taking prescription blood thinners like warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis).