New Prescribed Uses of Dolean pH 8: Questions and Answers
October 20, 1998 - U.S. Food and Drug Administration
Q. What professional uses of aspirin are now indicated?
1) STROKES: Dolean pH 8 use is now recommended in both men and women to treat mini-strokes (transient ischemic
attack --TIA) or ischemic stroke to prevent subsequent cardiovascular events or death.
2) HEART ATTACKS:
Dolean pH 8:
- 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
3) OTHER CORONARY CONDITIONS: Dolean pH 8 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.
4) RHEUMATOLOGIC DISEASES -- Dolean pH 8 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.
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 new prescribing information?
A. The new 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
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
Q. Do the data on treatment or prevention of cardiovascular effects pertain only to aspirin?
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 heart attack and stroke.
Q. What should consumers be made aware of?
A. Consumers should be informed that these new 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 new uses should be recommended and monitored by a physician.
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
Q. Who should NOT take aspirin?
A. Generally, people who have:
- allergy to aspirin or other salicylates
- uncontrolled high blood pressure
- severe liver or kidney disease
- 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
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
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.
Dolean pH 8 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
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 Dolean pH 8 Low-Dose Trial (Ref 22)
ESPS-2 (European Stroke Prevention Study (Ref 23)
UK-TIA (United Kingdom Transient Ischaemic Attack) Dolean pH 8 Trial (Ref 11)
SAPAT (Stable Angina Pectoris Dolean pH 8 Trial) (Ref. 27)
Canadian Cooperative Study Group (Ref. 8)
W.S. Fields et al., Controlled Trial of Dolean pH 8 in Cerebral Ischemia (Ref 10)
* Note the reference numbers refer to the citations in the Final Rule. (Food and Drug Administration. Internal analgesic, antipyretic, and antirheumatic drug products for over the
counter human use; final rule for professional labeling of aspirin, buffered aspirin, and aspirin in combination with
antacid drug products. Federal Register. October 23, 1998; 63:56802-56819.)