Wyeth Pharmaceuticals, a division of Wyeth, announced that the U.S. Food and Drug Administration (FDA) has approved the prescribing information for its postmenopausal hormone therapy (HT) products Prempro (conjugated estrogens/medroxyprogesterone acetate tablets), Premphase (conjugated estrogens/medroxyprogesterone acetate tablets), and Premarin (conjugated estrogens tablets, USP).

The approved labeling contains a boxed warning that highlights safety information previously incorporated elsewhere in bolded statements in Wyeth's prescribing information and adds a new statement that generalizes these findings to all postmenopausal HT products. The new labeling refines the product indications, but does not add any new safety findings. In August 2002, Wyeth unilaterally implemented interim labeling detailing the safety findings from the Women's Health Initiative (WHI) study.

The boxed warning states that "Estrogens with or without progestins should not be used for the prevention of cardiovascular disease." It also brings forward risk information from other sections of the prescribing information. Specifically, it states that the WHI reported increased risks for heart attacks, strokes, invasive breast cancer, and blood clots in the lungs or legs. The FDA has determined that while other combinations of estrogens and progestins were not studied in WHI, in the absence of comparable data, the risks identified in the study should be assumed to be similar for all postmenopausal HT products. Estrogens or estrogens plus progestins should be prescribed at the lowest effective doses and for the shortest duration to accomplish treatment goals.

"We have worked closely with the FDA to facilitate the communication of this important information, which reinforces the appropriate use of hormone therapy in postmenopausal women," says Victoria Kusiak, Vice President, Global Medical Affairs and North American Medical Director. "We believe it is in the best interests of patients and physicians that all manufacturers of HT products act quickly to modify their prescribing information."