Aspirin FAQ (cont.)

Q. What should consumers who are taking low dose aspirin for disease maintenance or prevention know about alcohol use?

A. Patients who consume 3 or more alcoholic drinks every day should be counseled about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.

Q. Can consumers safely use aspirin to treat suspected acute heart attacks?

A. If consumers suspect they are having a heart attack, their most important action must be to seek emergency medical care immediately. The advise and supervision of a doctor should direct this use of aspirin and patients are encouraged to speak with their doctor about this use.

Q. What do we know about how aspirin works for heart conditions and stroke?

A. The mechanism by which aspirin works in the treatment of heart attack and stroke is not completely understood. However, as an antiplatelet drug, we do know that aspirin help reduce platelet clumping which helps cause blockage in blood vessels.

Q. Who should NOT take aspirin?

A. Generally, people who have:

  • allergy to aspirin or other salicylates
  • bleeding disorders

Always check first with your doctor to determine whether the benefit of these professional uses of aspirin is greater than the risks to you.

Q. What other side effects are associated with aspirin?

A. There is a wide range of adverse reactions that may result from aspirin use including effects on the body as a whole, or on specific body systems and functions.

High doses can cause hearing loss or tinnitus-- ringing in the ears. (Note that this usually only occurs with large doses as prescribed in rheumatologic diseases and is rare in treatment with low doses used for cardiovascular purposes.)

Q. What is key message for Consumers?

A. The results of studies of people with a history of coronary artery disease and those in the immediate phases of a heart attack have proven to be of tremendous importance in the prevention and treatment of cardiovascular and cerebrovascular diseases.

Studies showed that aspirin substantially reduces the risk of death and/ or non-fatal heart attacks in patients with a previous MI or unstable angina pectoris which often occur before a heart attack. Patients with these conditions should be under the care and supervision of a doctor.

Aspirin has potential risks as well as benefits, like any drug. Patients should be careful to ask their doctor or health care professional before deciding whether aspirin is right for them and how much aspirin they should take.

Q. What were the major studies used to verify the effectiveness of aspirin for these indications?

A. Numerous studies both in the United States and abroad were evaluated to establish the safety and efficacy of aspirin for the cardiovascular and cerebrovascular indications and dosing information.

Major studies included:

  • ISIS - 2 (Second International Study of Infarct Survival) (Ref 7)
  • SALT (Swedish Aspirin Low-Dose Trial (Ref 22)
  • ESPS-2 (European Stroke Prevention Study (Ref 23)
  • UK-TIA (United Kingdom Transient Ischaemic Attack) Aspirin Trial (Ref 11)
  • SAPAT (Stable Angina Pectoris Aspirin Trial) (Ref. 27)
  • Canadian Cooperative Study Group (Ref. 8)
  • W.S. Fields et al., Controlled Trial of Aspirin in Cerebral Ischemia (Ref 10)

* Note the reference numbers refer to the citations in the Final Rule.

Date created: August 3, 2001, updated July 6, 2006

Source: Federal Drug Administration Center

Last Editorial Review: 4/5/2007