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The Food and Drug Administration (FDA) recently denied a request from Bayer, a manufacturer of aspirin, to expand the use of low-dose aspirin in the prevention of heart attacks, according to Dr. Steven Reisman, a Cardiologist in Manhattan. Previously the FDA in 1998 approved labeling for aspirin and related products in the secondary prevention of cardiovascular events. Secondary prevention includes use in those who have a history of coronary artery disease, previous heart attack, angina, and in those who have undergone revascularization procedures including coronary bypass surgery and angioplasty/stent placement.
In 2003 Bayer applied to the FDA to expand the indications for the use of aspirin for what is called primary prevention. In 2002 the American Heart Association recommended aspirin in primary prevention for those at increased risk for heart disease. The increased risk was defined as a 10 year risk of coronary heart disease greater than or equal to 10%. The goal was the prevention of heart attack.
Aspirin is effective by inhibiting blood clots and also by decreasing inflammation. The risks of aspirin use include allergy, gastrointestinal intolerance, and most importantly bleeding including gastrointestinal and intracerebral. After a review over several years the FDA recently denied the request by Bayer to include primary prevention because it felt the benefits did not outweigh the risks. The FDA noted that with further ongoing studies these recommendations may be expanded at a future date.
Aspirin at a low dose, or “baby” aspirin, is usually recommended at a dose of 81 milligrams per day in the secondary prevention of heart attack. This should only be started after consultation with a physician according to Dr. Steven Reisman, Director of the New York Cardiac Diagnostic Center, and a Manhattan Cardiologist. For primary prevention, Dr. Reisman recommends consultation with a Cardiologist to evaluate overall cardiovascular risk and to further define individual risk by non-invasive testing including stress testing, coronary calcium score, and evaluation of plaque buildup in the carotid artery.