Aspirin generally shouldn't be used to prevent heart attacks or stroke for patients with no history of the disease, the Food and Drug Administration said yesterday.
The use of the medicine raises serious risks of bleeding in the stomach and brain, the FDA said. While evidence shows that aspirin's benefits for people who have already had a cardiovascular event outweigh the increased risk of bleeding, the data don't support using the drug to help people prevent a first attack, the agency said.
On Friday, the FDA denied a request from Bayer, based in Leverkusen, Germany, to change the labeling on its packaging to market the product for heart-attack prevention for patients with no history of cardiovascular disease. Aspirin generated $1.27 billion in sales for Bayer last year.
"Importantly, the ruling does not impact the numerous cardiovascular indications for which aspirin is already approved by the FDA," said Anne Coiley, a spokeswoman for Bayer.
Aspirin didn't help prevent heart attacks or strokes in people with a high risk of heart disease yet don't show any symptoms, according to a Scottish study published in 2010 in the Journal of the American Medical Association. -- Bloomberg News