Evamist.com – Hormone therapy delivery evolved

Hormone therapy today is vastly different than it was 30 years ago. The benefits of using hormones to treat menopause were discovered well before all the risks were fully understood, especially at the high doses that were used in the past.¹ For some time it was thought that estrogen offered benefits in addition to easing the symptoms of menopause. For this reason, many doctors prescribed hormone therapy to women at high doses and for a long duration.¹

A brief history of menopause

It wasn’t until the late 19th century that the life expectancy for women reached age 45. By the early 20th century it had crept to 49—what we now consider middle age. Before then, most women could not expect to live beyond age 35, making menopause a virtually unheard of event.²

With more women beginning to experience menopause in the early 20th century, there came attempts to treat the new phenomenon. By 1942, the first orally active estrogen became available. This was essentially the beginning of the evolution of hormone therapy.²

In the early days of hormone therapy, many women were placed on relatively large doses of hormones and were instructed to take the medicine for the rest of their lives. Focus was on the myriad benefits, such as sustaining youth and sexuality. However, today we know that the high doses prescribed in the past are associated with higher risks for certain side effects.^1,2

New insight—the Women’s Health Initiative (WHI)

Let’s take a moment here to discuss an important development in the study of oral estrogens. As mentioned, many of the benefits of hormone therapy were known before the risks. To better understand the effects of hormone therapy, the National Institutes of Health (NIH) started the Women’s Health Initiative (WHI) studies.^2-4

Beginning in 1993, the WHI enrolled 161,809 menopausal women, ranging in age from 50 to 79, in a series of clinical trials and one

observational study. The intention was to look at the role of estrogen therapy (ET) and estrogen-progestin therapy (EPT) in the prevention of coronary heart disease (CHD). Several years of observational studies had suggested that hormone therapy had beneficial effects on heart disease, so the medical community was optimistic.^2-4

However, several years into the study, both the estrogen-only and estrogen-progestin arms of the study were stopped. The results were not what had been anticipated, leaving the medical community to re-evaluate hormone therapy. Women were suddenly left with more questions than answers.^2-4

» Read more about the history of hormone therapy

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 (estradiol transdermal spray) 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 (estradiol transdermal spray) may show signs of puberty that are not expected (for example, breast budding)

Evamist (estradiol transdermal spray) 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.