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New Analyses Indicate that Divigel(R) (estradiol gel) 0.1% Is a Valuable Option for Certain Postmenopausal Women With Hot Flashes
Date:9/25/2008

rombosis (DVT) or pulmonary embolism; active or recent arterial thromboembolic disease; liver dysfunction or disease; known hypersensitivity to Divigel(R) ingredients; or known or suspected pregnancy.

Estrogens increase the risk of endometrial cancer. Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent doses. Long-term continuous administration of estrogen, with or without progestin, has also shown increased risk of breast and ovarian cancers.

Cardiovascular and other risks. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) studies reported increased risks of stroke and DVT in postmenopausal women (50 to 79) during 6.8 and 7.1 years of treatment, respectively, with daily oral conjugated estrogens (CE) 0.625 mg alone, relative to placebo, and increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79) during 5.6 years of treatment with daily oral CE 0.625 mg and medroxyprogesterone acetate (MPA) 2.5 mg, relative to placebo.

The WHI Memory Study (WHIMS) reported increased risk of developing probable dementia in postmenopausal women 65 or older during 5.2 years of treatment with daily oral CE 0.625 mg alone and during 4 years of treatment with daily oral CE 0.625 mg and MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

These risks should be assumed to be similar for other combinations and dosage forms of estrogens and progestins.

Less common but serious risks reported with est
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SOURCE Upsher-Smith Laboratories, Inc.
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