Although evidence indicates that aspirin's benefits outweigh its bleeding risks for patients with a history of a cardiovascular event, the data do not support the use of the drug for the prevention of first heart attack, the agency said. The FDA released the statement in response to Bayer's request to change its aspirin product labeling.
The use of the medicine raises serious risks of bleeding in the stomach and brain, the statement 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 doesn't support using the drug to help people prevent a first attack.
On May 2, the FDA denied a request from Leverkusen, Germany-based Bayer AG 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 916 million euros ($1.27 billion) in sales for Bayer last year.
Anne Coiley, a spokeswoman for Bayer, said in an e-mail, "Importantly, the ruling does not impact the numerous cardiovascular indications for which aspirin is already approved by the FDA."
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 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 placebo, the researchers said.
Allen Taylor, professor at Georgetown University School of Medicine and chief of cardiology at MedStar Georgetown University Hospital and MedStar Washington Hospital Center, added that, "It's a useful statement to warn people that aspirin is not a blanket therapy."
- Start the conversation with your patients and question them about their use of aspirin
- Many patients are taking the daily aspirin due to the quantity of advertising seen
- Have the conversation about the use of aspirin and the risk versus benefits
FDA News Release, May 5, 2014