- What are the different uses for aspirin?
- What does this mean for doctors and medical practice?
- What is the basis for the prescribing information?
- What does this mean for patients?
- Is FDA concerned that some patients may self-treat?
- If a consumer is interested in using aspirin to prevent or treat symptoms of heart problems, what should he or she do?
- Do the data on treatment or prevention of cardiovascular effects pertain only to aspirin?
- What should consumers be made aware of?
- What should consumers do if they are taking other pain medications such as ibuprofen?
- What should consumers who are taking low dose aspirin for disease maintenance or prevention know about alcohol use?
- Can consumers safely use aspirin to treat suspected acute heart attacks?
- What do we know about how aspirin works for heart conditions and stroke?
- Who should NOT take aspirin?
- What other side effects are associated with aspirin?
- What is key message for Consumers?
- What were the major studies used to verify the effectiveness of aspirin for these indications?
- 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:
- 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, spondylarthropathies, and arthritis and pleurisy associated with systemic lupus erythematosus.
- Pain relief: Aspirin is indicated for the temporary relief of minor aches and pains.
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.
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 in patients who have cardiovascular disease or who have already had a heart attack or stroke. 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.
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.
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.
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."
A. Yes. Although acetaminophen, ibuprofen, naproxyn sodium and ketoprofen are good drugs for pain and fever, as is aspirin, only aspirin has demonstrated a beneficial effect for preventing another heart attack or stroke in patients who have cardiovascular disease or who have already had a heart attack or stroke.
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.
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.
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.
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.
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.
A. Generally, people who have:
Always check first with your doctor to determine whether the benefit of these professional uses of aspirin is greater than the risks to you.
- allergy to aspirin or other salicylates
- uncontrolled high blood pressure
- severe liver or kidney disease
- bleeding disorders
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.)
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.
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.