FDA questions use of aspirin to prevent first heart attack

The U.S. Food and Drug Administration on Monday questioned the value of taking aspirin to try to ward off a first heart attack or stroke in people who have never had cardiovascular problems.

The FDA's statement follows its decision last week to turn down a request by German drugmaker Bayer AG to change the labeling on packages in order to market aspirin's value in preventing heart attacks in people who have never had cardiovascular disease.

Dr. Robert Temple, the agency's deputy director for clinical science, said in an FDA "consumer update" that people should use daily aspirin therapy only after talking to a healthcare professional who can assess the benefits and risks.

Such aspirin therapy reduces the clumping action of the blood's clotting cells, called platelets, and may prevent a heart attack, according to experts. But experts also warn that there may be serious side effects from daily use of aspirin, including internal bleeding.

"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," Temple said in a statement on the FDA website.

But the agency added that "after carefully examining scientific data from major studies, 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.'"

The FDA said that in these people "the benefit has not been established but risks - such as dangerous bleeding into the brain or stomach - are still present."

Some health organizations back daily aspirin therapy for people identified as having a high risk of suffering a heart attack. The American Heart Association recommends that "people at high risk of heart attack should take a daily low dose of aspirin if told to by their healthcare provider, and that heart attack survivors regularly take low-dose aspirin."

Dr. Gregg Fonarow, a UCLA cardiologist and a representative for the American Heart Association, said the FDA has further clarified its position on whether it meets regulatory standards to allow a label for aspirin for primary prevention of heart attack and stroke.

Aspirin and heart disease

Taking aspirin helps prevent blood clots from forming in your arteries. It also lowers your risk of a stroke or heart attack.

Aspirin may be used to prevent heart or artery disease. It can also help prevent strokes.

Aspirin helps get more blood flowing to your legs. It can treat a heart attack and prevent blood clots when you have an abnormal heartbeat. You probably will take aspirin after you have treatment for clogged arteries.