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New Data: Efficacy and Responder Analyses of Divigel(R) (estradiol gel) 0.1 percent for the Treatment of Menopause
Date:6/30/2009

idual-use packets. One packet of gel is applied daily to an area that measures approximately 5 x 7 inches on the thigh, the smallest application area compared to all other available gel or lotion estrogen products.(1-4)

Divigel(R) was approved by the U.S. Food and Drug Administration (FDA) in June 2007.

Important Safety Information for Patients

The following are not all the possible risks for Divigel(R). Please see the full Prescribing Information and talk to your healthcare provider.

Estrogens increase the chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. 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. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer and blood clots.

Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.

Do not use estrogen products, including Divigel(R), if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel(R) ingredients or think you may be pregnant.

The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating,
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SOURCE Upsher-Smith Laboratories, Inc.
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