The U.S. Food and Drug Administration (FDA) has asked that all labels on estrogen and estrogen-progestin replacement therapy be revised to carry a boxed warning, stating the increased risks for heart disease, heart attacks, strokes, and breast cancer.
The warning also emphasizes that these products are not approved for heart disease prevention. “We have approved all new labeling for Wyeth Pharmaceuticals for Prempro, Premarin, and Premphase,” said FDA spokesperson Pam Winbourne, in a teleconference with reporters. “All other manufacturers are being faxed letters asking them to revise their labels in a similar fashion.
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