Do Not Take Daily Aspirin if You Haven’t Had a Heart Attack, Says FDA

Taking a daily aspirin is not necessary for people with no history of heart problems, the U.S. Food and Drug Administration says.

In a newly released consumer update bound to cause a stir for the 40 million Americans who take aspirin every day, the FDA says it has combed the evidence and concluded that people who have not had heart problems, even if they have a family history of it, will not benefit from taking a daily aspirin.

The announcement comes after the FDA denied Bayer’s request to change its aspirin labels to say aspirin can aid in the prevention of heart attacks in people without a history of heart disease.

On its website, the FDA has written, “FDA has concluded that the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called ‘primary prevention.’ In such people, the benefit has not been established but risks — such as dangerous bleeding into the brain or stomach — are still present.”

Dr. Robert Temple, deputy director for clinical science at the FDA, said in the recommendation that since the 1990s there has been clinical data showing that people who have undergone a heart attack, stroke or any blood vessel disease in the heart can benefit from taking a daily low dose of aspirin and can lower the risk of having another adverse heart event. This is what the FDA refers to as “secondary prevention.”

Currently, large-scale clinical studies are ongoing to look at the risks and benefits of primary prevention with daily aspirin, and the FDA is monitoring those studies.

The FDA says the bottom line is that people who have undergone a heart attack or have other heart-related problems can consider taking a daily aspirin, but everyone should consult with their physician over what’s the best option for them.