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Important Safety Information
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WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER, PROBABLE
DEMENTIA and UNINTENTIONAL SECONDARY EXPOSURE TO ESTROGEN
See full prescribing information for complete boxed warning
Estrogen-Alone Therapy
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There is an increased risk of endometrial cancer in a
woman with a uterus who uses unopposed estrogens
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Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
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The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
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The WHI Memory Study (WHIMS) estrogen-alone ancillary
study of WHI reported an increased risk of probable dementia in postmenopausal women
65 years of age and older
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Estrogen Plus Progestin Therapy
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Estrogen plus progestin therapy should not be used for
the prevention of cardiovascular disease or dementia
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The WHI estrogen plus progestin substudy reported increased
risks of stroke, DVT, pulmonary embolism, and myocardial infarction
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The WHI estrogen plus progestin study reported increased
risks of invasive breast cancer
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The WHIMS estrogen plus progestin ancillary study of WHI
reported an increased risk of probable dementia in postmenopausal women 65 years
of age and older
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Estrogens with or without progestins should be prescribed at the lowest effective
doses for the shortest duration consistent with the treatment goals for the individual
woman.
Unintentional Secondary Exposure
Breast budding and breast masses in prepubertal females and gynecomastia and breast
masses in prepubertal males have been reported following unintentional secondary
exposure to Evamist by women using this product. In most cases, the condition resolved
with removal of Evamist exposure. Women should ensure that children do not come
into contact with the site(s) where Evamist is applied. Healthcare providers should
advise patients to strictly adhere to recommended instructions for use.
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Evamist is an estrogen indicated for the treatment of moderate to severe vasomotor
symptoms due to menopause.
Evamist should not be used in women with undiagnosed abnormal genital bleeding;
known, suspected, or history of breast cancer; known or suspected estrogen-dependent
neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these
conditions; active or recent arterial thromboembolic disease; liver dysfunction
or disease; or known or suspected pregnancy.
In a clinical trial with Evamist the most common side effects were headache, breast
tenderness, nipple pain, nausea, back pain and nasopharyngitis
Please see
full prescribing information for Evamist, including boxed warnings.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
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