Ther-Rx - Evamist - Footnote References

1. Nathan L. Menopause and postmenopause. In: DeCherney AH, Nathan L, Goodwin TM, Laufer N, eds. Current Diagnosis and Treatment Obstetrics and Gynecology. 10th ed. McGraw-Hill’s AccessMedicine. Available at: www.accessmedicine.com. Accessed March 3, 2008.

2. Data on file. Ther-Rx Corporation.

3. The North American Menopause Society. Early menopause guidebook: helping women make informed decisions. Available at: http://www.menopause.org/edumaterials/earlyguidebook/emgtoc.aspx. Accessed February 18, 2008

4. AACE Menopause Guidelines Revision Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocr Pract. 2006;12:315-337.

5. Hot flashes team up with insomnia to disrupt sleep. http://www.redhotmamas.org/content/index.php?option=com_content&task=view&id=72&Itemid=5. Accessed August 11, 2008.

6. Ohayon MM. Severe hot flashes are associated with chronic insomnia. Arch Intern Med. 2006;166:1262-1268.

Important Safety Information

Evamist^® is approved by the FDA for use after menopause to reduce moderate-to-severe hot flashes.

Estrogens increase the 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. Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogen, with or without progestins, may increase your risk of dementia, based on a study of women age 65 years or older. 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.

You and your healthcare provider should talk regularly about whether you still need treatment with Evamist.

Please see full prescribing information for Evamist.

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.