FDA approves new uses for aspirin

December 1, 1998
Pharmaceutical Representative

The Food and Drug Administration issued a new rule that approves aspirin for expanded uses in patients with cardiovascular and cerebrovascular problems.

The Food and Drug Administration issued a new rule that approves aspirin for expanded uses in patients with cardiovascular and cerebrovascular problems. The rule also explains how aspirin can be used in the treatment of rheumatologic conditions.

The agency's approval of the new uses will be reflected in changes in labeling for over-the-counter aspirin, buffered aspirin and aspirin in combination with antacid.

The revised labeling recommends aspirin for use in men and women to treat transient ischemic attack (sometimes referred to as "mini strokes," ischemic stroke, angina, acute myocardial infarction, recurrent myocardial infarction, specific revascularization procedures and rheumatologic diseases.

The rule does not, however, recommend or suggest that healthy men and women take aspirin to lower their risk of heart attack. Based on multiple studies in the United States and abroad, the FDA concluded that "there are insufficient data to recommend that use of aspirin in patients with peripheral vascular disease, such as those experiencing intense leg pain due to blockage of blood flow to that area of the body."

Dosages as low as 50 mg are recommended for cardiac and cerebral vascular uses, although that amount can go as high as 325 mg. For angina and previous heart attack, the FDA recommends doses of 75 mg to 325 mg.

In conjunction with the new rule, the FDA issued a statement discouraging self-treatment by patients with stroke and cardiovascular conditions. "Patients with these conditions should be under the care and supervision of a doctor," the agency said in a formal statement. "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."

For example, the agency noted, aspirin has been linked to internal bleeding, and that the risk of bleeding goes up in patients who consume three or more alcoholic drinks per day. Furthermore, patients with allergy, asthma, uncontrolled high blood pressure, severe liver or kidney disease or bleeding disorders should not take aspirin. Lifestyle and health factors such as these should be taken into consideration by a physician before a patient undergoes aspirin therapy.

The National Stroke Association issued its support of the FDA's decision.

"These guidelines strengthen the notion that low-dose aspirin is an effective way to reduce stroke risk - a question that has always troubled physicians," said J. Donald Easton, M.D., professor and chairman of the department of clinical neurosciences at Brown University and the Rhode Island Hospital. "Low-dose aspirin can also increase patient comfort by reducing the gastrointestinal side effects of aspirin."

The National Stroke Association also pointed out that studies showed that combining aspirin with dipyridamole, an antiplatelet agent, reduced the risk of secondary stroke by 37%. Aspirin alone reduced risk by 18%. The extended-release dipyridamole and low-dose aspirin combination will be submitted to the FDA for labeling approval as prevention for secondary stroke by the end of the year, according to the association. PR