Aspirin FAQ (cont.)

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?