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    775345

    (FDA to require distribution of brochure explaining the benefits and risks of the hormone estrogen) (Press release)

    United States. Food and Drug Administration [FDA]

    Washington, D.C., USDHEW, October 17, 1977. 3 p

    Effective October 18, 1977, women receiving prescriptions for drugs containing the female sex hormone estrogen must be given a special lay-language brochure explaining the benefits and risks of the drug. About 5,000,000 women in the U.S. use estrogen-containing prescription drugs every year to treat menopausal or postmenopausal problems. The brands prescribed include Premarin, Hormonin, Estratab, Evex, Menest, Femogen, and Ogen. Donald Kennedy, Commissioner of Food and Drugs, has stated that FDA has become increasingly concerned that estrogens are used too frequently and for too long a period. The brochure, to be printed and supplied by manufacturers of the drugs, indicates that estrogens are associated with cancer of the uterus when used for extended periods. Additionally, the brochure advises women to take estrogen drugs for the shortest time possible and in the lowest effective dose for treatment of menopausal systems and to reevaluate, with their doctors, the need for estrogen every 6 months. It states that these drugs should not be used to treat simple nervousness and depression during menopause because they have not been shown to be effective for these purposes and that they have not been shown to be effective for keeping the skin soft or for helping women feel younger after menopause.
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