Aspirin to prevent heart attack should be limited, FDA says
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 916 million euros ($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,” Anne Coiley, a spokeswoman for Bayer, said in an e-mail.
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 placebo, the researchers said.
“It’s a useful statement to warn people that aspirin is not a blanket therapy,” said Allen Taylor, professor at Georgetown University School of Medicine and chief of cardiology at MedStar Georgetown University Hospital and MedStar Washington Hospital Center, in a telephone interview. “It’s not innocuous.”
He 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 they will recommend anti-clot drugs like Bristol-Myers Squibb Co.’s Plavix that can carry a different set of benefits and risks, Taylor said.
Rules for posting comments
Comments posted below are from readers. In no way do they represent the view of Stephens Media LLC or this newspaper. This is a public forum.
Comments may be monitored for inappropriate content but the newspaper is under no obligation to do so. Comment posters are solely responsible under the Communications Decency Act for comments posted on this Web site. Stephens Media LLC is not liable for messages from third parties.
IP and email addresses of persons who post are not treated as confidential records and will be disclosed in response to valid legal process.
Do not post:
- Potentially libelous statements or damaging innuendo.
- Obscene, explicit, or racist language.
- Copyrighted materials of any sort without the express permission of the copyright holder.
- Personal attacks, insults or threats.
- The use of another person's real name to disguise your identity.
- Comments unrelated to the story.
If you believe that a commenter has not followed these guidelines, please click the FLAG icon below the comment.