Aspirin: Questions and Answers

Q. What are the different uses for aspirin?

• Strokes: Aspirin use recommended in both men and women to treat mini-strokes (transient ischemic attack [TIA]) or ischemic stroke to prevent subsequent cardiovascular events or death.
   
• Heart Attacks:
   
  • Aspirin:
     
    • reduces the risk of death in patients with suspected acute heart attacks (myocardial infarctions)
       
    • prevents recurrent heart attacks and
       
    • reduces the risk of heart attacks or sudden death in patients with unstable and chronic stable angina pectoris (chest pain).
       
• Other coronary conditions: Aspirin can be used to treat patients who have had certain revascularization procedures such as angioplasty, and coronary bypass operations -- if they have a vascular condition for which aspirin is already indicated.
  
   
• Rheumatologic diseases: Aspirin is indicated for relief of the signs and symptoms of rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, spondyloarthropathies, and arthritis and pleurisy associated with systemic lupus erythematosus.
  
   
• Pain relief: Aspirin is indicated for the temporary relief of minor aches and pains.

Q. What does this mean for doctors and medical practice?

A. Doctors and health care professionals will be provided with full prescribing information about the use of aspirin in both men and women who have had a heart attack, stroke, certain other cardiovascular conditions and rheumatologic diseases. For stroke and cardiovascular conditions, lower doses are recommended than those previously prescribed by physicians in practice. Information on the use of aspirin for rheumatologic diseases has also been expanded to include specific dosing information as well as information about side effects and toxicity. Thus, doctors will have full prescribing information on aspirin and the assurance that aspirin is a safe and effective treatment for heart attacks, strokes, certain other vascular conditions and rheumatologic diseases.

Q. What is the basis for the prescribing information?

A. The information on the uses of aspirin is based on scientific studies that support treatment with aspirin for heart attacks, strokes, and some related conditions. Convincing data support these uses in lower doses than previously believed to be effective in treating heart attacks and strokes in both men and women.

Q. What does this mean for patients?

A. Physicians will be better able to prescribe the proper doses for these uses for male and female patients with these medical conditions. Dose-related adverse events for patients with stroke and cardiovascular conditions should be minimized because lower dosages are recommended. The full prescribing information now provided for physicians who treat rheumatologic diseases will enhance the safe and effective prescribing of aspirin to these patients as well.

Q. Is FDA concerned that some patients may self-treat?

A. FDA emphasizes that consumers should not self-medicate for these serious conditions because it is very important to make sure that aspirin is their best treatment. In these conditions, the risk and benefit of each available treatment for each patient must be carefully weighed. Patients with these conditions should be under the care and supervision of a doctor.

Q. If a consumer is interested in using aspirin to prevent or treat symptoms of heart problems, what should he or she do?

A. Consumers should always first ask their doctor. In fact, aspirin products are labeled this way: "Important: See your doctor before taking this product for other new uses of aspirin because serious side effects could occur with self treatment."

Q. Do the data on treatment or prevention of cardiovascular effects pertain only to aspirin?

A. Yes. Although acetaminophen, ibuprofen, naproxen sodium and ketoprofen are good drugs for pain and fever, as is aspirin, only aspirin has demonstrated a beneficial effect for heart attack and stroke.

Q. What should consumers be made aware of?

A. Consumers should be informed that these professional uses of aspirin may be lifesaving when used upon the recommendation and under the supervision of a doctor. However, they must also be informed that even familiar and readily available products like aspirin may have important risks when used in new ways. For example, because aspirin can cause bleeding; in rare cases bleeding in the brain may occur in people who are using aspirin to prevent stroke. Therefore these uses should be recommended and monitored by a physician.

Q. What should consumers do if they are taking other pain medications such as ibuprofen?

A. Consumers who have been told by their doctor to take aspirin to help prevent a heart attack, should know that taking ibuprofen at the same time, for pain relief, may interfere with the benefits of aspirin for the heart. It is alright to use them together, but the FDA recommends that consumers contact their doctor for more information on the timing of when to take these two medicines, so that both medicines can be effective.