The Food and Drug Administration (FDA) last week denied a request by German drug maker Bayer AG to change the label on packages of its aspirin to promote the benefits of regular aspirin therapy to ward off first heart attack or stroke in people who have never had cardiovascular problems. Now the agency is questioning whether the treatment carries any value to those with no heart issues and whether taking a daily aspirin may actually put these individuals at risk for potentially serious side effects.
Aspirin therapy is often recommended for people with cardiovascular disease because it reduces the clotting effects in the blood and thus may prevent a heart attack. But like all anticoagulants, blood that is too thin can lead to dangerous internal bleeding such as in the brain or stomach.
Since the 1990s, data has suggested that aspirin therapy could help prevent a second cardiovascular event in people who have had a heart attack, stroke or a disease of the blood vessels in the heart. However, the FDA said that after carefully examining scientific data from major studies, it has concluded that the data does not support the use of aspirin as a preventative medication for those who have never had a heart attack or stroke.
The agency added that it is critical that patients currently on aspirin therapy remain on the medication. Stopping aspirin therapy suddenly can be dangerous. People with questions about their aspirin therapy should talk with their doctors.