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There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogensAdding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasiawhich may be a precursor to endometrial cancerAdequate diagnostic measuresincluding directed or random endometrial sampling when indicatedshould be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
The Women’s Health InitiativeWHIestrogen-alone substudy reported increased risks of stroke and deep vein thrombosisDVTin postmenopausal women with daily oral conjugated estrogensCEaloneThe WHI estrogen-plus-progestin substudy reported increased risks of DVTpulmonary embolismstrokeand myocardial infarction in postmenopausal women with daily oral CE combined with medroxyprogesterone acetateMPAIn the absence of comparable datathese risks should be assumed to be similar for other dosage forms of estrogens.
The distribution of exogenous estrogens is similar to that of endogenous estrogensEstrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organsEstrogens circulate in the blood largely bound to sex hormone binding globulinSHBGand albumin.
Severe headache or vomitingdizzinessfaintnesschanges in vision or speechweakness or numbness of an arm or legpossible clot in the brain or eye)
Safety and effectiveness in pediatric patients have not been establishedLarge and repeated doses of estrogen over an extended period of time have been shown to accelerate epiphyseal closureresulting in short adult stature if treatment is initiated before the completion of physiologic puberty in normally developing childrenIn patients in whom bone growth is not completeperiodic monitoring of bone maturation and effects on epiphyseal centers is recommended.
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