A daily dose of aspirin should not be used routinely to prevent a first heart attack or stroke in people who don’t have cardiovascular disease or evidence of heart disease, according to U.S. regulators. They cite a lack of research showing such treatment is beneficial to those who aren’t at higher risk, and mention serious side effects like gastrointestinal bleeding, bleeding strokes and drug interactions.

In an interview, Lori Mosca, M.D., Ph.D., director of Preventive Cardiology at New York-Presbyterian Hospital and professor of medicine Columbia University Medical Center in New York City offers direction on the American Heart Association’s guidelines.

1. What did the Food and Drug Administration say about taking aspirin to prevent a first heart attack or stroke?

The FDA issued a public service advisory on May 2  to clear misperceptions about the use of aspirin to prevent heart attacks and strokes. When aspirin is used to prevent a first heart attack or stroke, it’s known as primary prevention. Regulators said medical research does not justify the general daily use of aspirin for primary prevention in people who don’t have cardiovascular disease or who aren’t at higher risk. The FDA also mentioned serious side effects that can occur.

Regulators said that evidence continues to support the use of aspirin to prevent a heart attack or stroke in patients who had already had a heart attack or stroke, or who have coronary artery disease.  This is known as secondary prevention. The known benefits of aspirin in these cases outweighs the risk of side effects.

2. Why did the FDA issue this advice now?

The FDA advisory was partly based on a drug manufacturer’s recent request to add information on its labels saying that aspirin could be used for prevention purposes. The FDA said “no” and issued the advice.

3. Does this affect people taking aspirin to prevent another heart attack or stroke on their doctor’s recommendation?

“It’s critically important that patients who have heart disease should not stop taking aspirin and they should talk to their doctors if they have questions.  I want patients to hear this right away,” said Dr. Mosca, a national volunteer for the AHA.

4. What does the AHA say about aspirin?

The AHA recommends that people who are at risk of heart attack, or who have had a heart attack, should take a daily low-dose of aspirin only if it is recommended by their healthcare provider.  “The AHA has been committed for a long time to providing the public with important information about aspirin and has spearheaded guidelines to help providers determine who would benefit from it,” said Mosca.

5. What does the American Heart Association say about the FDA advisory?

“This advisory reinforces the AHA’s guidelines and the need to raise public awareness about the potential benefits and risks of aspirin. The AHA has found there are a lot of misperceptions about the benefits of aspirin,” Mosca said.

For many patients, especially those without an elevated risk for heart disease, the routine use of aspirin is typically not recommended, she said.

6. What are the side effects of taking aspirin daily?

The side effects and complications of aspirin vary, depending on the person taking it and the amount they’re taking. However, the most common complications are:

  • Bleeding in the stomach or gastrointestinal tract;
  • Worsening strokes caused by bleeding in the brain;
  • Interactions with other blood thinners, such as warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis);
  • Increased bleeding during medical or dental procedures;
  • Aspirin allergies or intolerance.

7. How common are these side effects?

“These side effects are not common but they can be life-threatening, and therefore, the use of aspirin to prevent a first heart attack should be made under the guidance of a healthcare provider,” said Mosca.

8. Does coated aspirin protect people from the side-effects? How about low-dose aspirin, once referred to as “baby aspirin”?

Mosca said people who would benefit from aspirin therapy should talk about the appropriate dose and type of aspirin with their doctor. She said most physicians believe a low dose is beneficial for the heart and has fewer side effects. Coated aspirin may help prevent some gastrointestinal side effects. However, there are important caveats for people who think they may be having a heart attack.

9. If someone thinks they’re having a heart attack, should they take an aspirin?

Anyone who may be having a heart attack should immediately call 9-1-1.  The dispatcher may tell the caller to chew an aspirin, said Mosca.

10. How do blood thinners help prevent heart attacks or strokes?

Most heart attacks or strokes are caused by clots that block blood flow and damage the heart or brain. Because blood thinners limit the ability to form clots, they can minimize these risks. Although aspirin is an over-the-counter drug, a doctor should guide its daily use, taking into account a patient’s individual health, risk factors, alcohol consumption, and other medications.

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