A brief history of menopause and hormone therapy

Making sense of the results

Women in the study were older, predisposing them to disease

They were many years past their last period and had no current menopausal symptoms

Today, the limitations in the design of the original trial are acknowledged, but the results remain important to how hormone therapy is prescribed today. Researchers were able to better see the risks involved with long-term use of higher doses of estrogen in older patients.² This study and its observations were the basis for safety information for all estrogen therapies regardless of the route of administration.

After several years of evaluation, hormone therapy has re-established its position as an important option for women experiencing menopausal symptoms. Doctors agree that hormone therapy should always be used at the lowest effective dose for the shortest amount of time needed to control the symptoms of menopause.^1,5

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Important Safety Information

What is the most important information I should know about Evamist (an estrogen hormone)?

•	Using estrogen alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Evamist. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
•	Do not use estrogen alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
•	Using estrogen alone may increase your chances of getting strokes or blood clots
•	Using estrogen alone may increase your chance of getting dementia, based on a study of women 65 years or older
•	Do not use estrogens with progestins to prevent heart disease, heart attack or dementia
•	Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
•	Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years and older
•	You and your healthcare provider should talk regularly about whether you still need treatment with Evamist
•	The estrogen in Evamist spray can transfer from the area of skin where it was sprayed to other people. Do not allow others, especially children, to come into contact with the area of your skin where you sprayed Evamist. Young children who are accidentally exposed to estrogen through contact with women using Evamist may show signs of puberty that are not expected (for example, breast budding)

Evamist is an estrogen hormone used after menopause to reduce moderate to severe hot flashes.

Evamist should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the past year; currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.

The most common side effects that may occur with Evamist are headache, breast tenderness, the common cold, nipple pain, back pain, nausea, and joint pain.

Please see full patient information for Evamist.

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.