The U.S. Food and Drug Administration announced yesterday labeling changes to Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets) and Premarin (conjugated estrogens tablets).
The labeling reflects new data, mainly from the Women’s Health Initiative, which was stopped in July 2002 due to safety concerns. The new labeling stresses that none of the therapies should be used to prevent coronary heart disease.
In addition, because of the newly discovered risk of cardiovascular events, breast cancer, and venous thromboembolism, use of the drugs should be limited to as short a duration as possible. Patients receivings any of these drugs also should be reevaluated on a regular basis. In addition, physicians who prescribe one of these drugs solely for postmenopausal osteoporosis prevention should consider alternative therapies.
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