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WHI data prompt strict warnings on hormone products: black box warning must be added to all estrogen and estrogen-progesterone products. (Wyeth Revises Indications).
ROCKVILLE, MD. -- A black box warning outlining the increased risks of heart disease, myocardial infarction, stroke, and breast cancer is now required in the labeling of all estrogen and estrogen-progesterone products.
The Food and Drug Administration last month announced the addition of the black box, the strongest warning that can be made in a drug label. The agency also revised two approved indications for these products and made other labeling changes.
The moves come as a result of an FDA analysis of the raw data from one arm of the Women's Health Initiative (WHI), which was published last summer. That part of the trial was halted 3 years early when the estrogen-progestin combination (Prempro) used in the study was linked to a doubling in the risk of pulmonary emboli and deep vein thrombosis and an increased risk of stroke, MI, invasive breast cancer, and total cardiovascular disease. The estrogen (Premarin)-only arm is continuing, and results are expected in 3 years.
The FDA also announced last month that it had approved new physician labeling and new patient information leaflets incorporating these changes for Wyeth's Prempro and Prem phase (conjugated estrogens/medroxyprogesterone) and Premarin (conjugated estrogens).
Furthermore, in letters sent to manufacturers of other currently available estrogen and estrogen-progesterone products, "all manufacturers are being asked to revise their labeling in a similar fashion," said Dr. Florence Houn, director of the FDA's Office of Drug Evaluation III, in the Centers for Drugs Evaluation and Research.
Dr. Wulf Utian, executive director of the North American Menopause Society said in an interview that the FDA's application of the changes to all estrogen and estrogen-progestin products is "quite reasonable ... as we await further evidence on safety and efficacy of estrogen alone, different routes of administration, lower doses, and ...
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