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FDA Adds Warning Labels To Hormone Therapy Products

Jan 9, 2003 | AP

The government announced new warnings yesterday on the labels for hormone replacement therapies and advised millions of post-menopausal women to consult their doctors about whether to continue treatment.

The Food and Drug Administration acted after reviewing information from a landmark study that found that the increased risk of heart disease and breast cancer from using therapies combining the hormones estrogen and progestin far outweighed any health benefits. The government abruptly halted that study last July.

The FDA approved new labels for Wyeth Pharmaceuticals, maker of the best-selling hormone brands, that includes a new boxed warning highlighting the increased risk for heart disease, heart attacks, strokes and breast cancer. They also include a reference to the study findings.

The new labels also emphasize that these products are not approved for the prevention of heart disease. The aborted study was examining the effect of the combination estrogen-progestin hormone therapy on heart disease prevention, using Wyeth's Prempro brand product.

The FDA also said it was asking all manufacturers of estrogen and estrogen-progestin products to add similar warnings and change the enclosed patient information leaflet because all hormone products are believed to carry similar health risks.

The new labels also advise doctors to prescribe the lowest dose possible for the shortest period of time, since it isn't yet known what dose may reduce the risk of serious side effects.

For women who rely on hormone replacement to cope with the uncomfortable side effects of menopause and are confused about whether to start or continue treatment, FDA Commissioner Mark McClellan said that decision is best made on an individual basis, in consultation with a doctor.

In two instances, for treating vaginal dryness and irritation, and preventing the bone-weakening disease osteoporosis after menopause, the labels now suggest non-hormonal treatments.

The FDA advised women who decide to use hormone therapy after consulting their doctors to have yearly breast exams by a health professional, perform monthly breast self-exams, get periodic mammograms and discuss other ways to reduce the risk of heart disease and osteoporosis.

Wyeth Pharmaceuticals, based in Saint Davids, Pa., said yesterday that it was sending revised prescription information to more than half a million doctors and other health care providers.

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