
bkdaniels
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Apr 24, 2005, 6:49 PM
Post #3 of 4
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Hey natying, how are you doing? The agency encourages all health care professionals to report any cases of cardiac valvular disease or other serious toxicities associated with the use of fenfluramine, dexfenfluramine, or phentermine to the FDA's MEDWATCH program at 1-800-FDA-1088/fax 1-800-FDA-0178; or to the respective drug manufacturers. In a letter to doctors, FDA noted that as of July 8, 1997, the agency has received reports of 33 cases of unusual abnormalities in mitral, aortic, and tricuspid heart valves in women between the ages of 30 and 72 who had been taking fenfluramine and phentermine for 1 month to 28 months. In addition, the agency is notifying manufacturers to meet with FDA to discuss possible labeling changes. Because of the seriousness of the cardiac problems and their rare occurrence in otherwise healthy obese women in this age range, FDA believes patients and health care professionals should be notified of this information. Best wishes,
(This post was edited by bkdaniels on May 22, 2005, 7:49 PM)
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