FDA to reassess hormone replacement risks

Alleviating hot flashes is a motivation for many women taking Prempro and other hormone replacement therapies.

WASHINGTON (CNN) -- The Food and Drug Administration's Center for Drug Evaluation and Research has announced it will reassess the risks and benefits of Prempro, a hormone replacement therapy drug.

In a statement Tuesday, the FDA said that the Department of Health and Human Services will host public sessions on the issue in the fall. It said that other combination estrogen/progestin products will be considered and that the findings may affect future clinical trials of hormone replacement therapy.

In July, the National Heart, Lung and Blood Institute announced that it was stopping a hormone replacement study assessing whether long-term use of Prempro, the leading estrogen-progestin combination, would reduce the risk of coronary heart disease in postmenopausal women.

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The study by the Women's Health Initiative was halted early because of health risks, primarily breast cancer and coronary heart disease, and lack of overall benefits of the drug.

Prempro, made by Wyeth Pharmaceuticals, is used for the treatment of moderate to severe menopausal symptoms such as hot flashes, night sweats and vaginal dryness and for the prevention of osteoporosis in postmenopausal women.

To date, no estrogen/progestin combination product has received FDA approval for the prevention of coronary heart disease.