Aspirin generally shouldn't be used to prevent heart attacks or stroke for patients with no history of the disease, U.S. regulators said Monday.
The use of the medicine raises serious risks of bleeding in the stomach and brain, the Food and Drug Administration said in a statement. While evidence shows that aspirin's benefits for people who have already had a cardiovascular event outweigh the increased risk of bleeding, the data doesn't support using the drug to help people prevent a first attack, the agency said.
The FDA on May 2 denied a request from Leverkusen, Germany-based Bayer 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," Bayer spokeswoman Anne Coiley said in an email.
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 the Journal of the American Medical Association in 2010. Higher-risk people had a similar number of attacks and strokes as participants taking a placebo, the researchers said.
"It's a useful statement to warn people that aspirin is not a blanket therapy," Allen Taylor, a Georgetown University School of Medicine professor and chief of cardiology at MedStar Georgetown University Hospital and MedStar Washington Hospital Center, said in a phone interview. "It's not innocuous."
Dr. Taylor said the FDA statement could help patients who often buy aspirin over-the-counter start having conversations with their doctors, or prevent younger, less-at-risk patients from using aspirin.
When doctors aren't prescribing aspirin, he said, they will recommend anti-clot drugs such as Bristol-Myers Squibb Co.'s Plavix that can carry a different set of benefits and risks.