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Inadvertent Contact with Evamist Menopause Spray Dangerous to Children and Pets, FDA Warns

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August 1, 2010

Children and pets inadvertently exposed to Evamist spray, a treatment for hot flashes during women’s menopause, are at risk of developing hormone related side effects, said the U.S. Food and Drug Administration (FDA) in an agency advisory.

Evamist is a transdermal spray containing estradiol, an estrogen hormone, applied daily by menopausal women to the forearm between the wrist and elbow to reduce hot flashes.

“Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “It is important that people know to keep both children and pets away from the product to minimize exposure.”

The FDA is currently is reviewing reports of adverse events in children and pets inadvertently exposed to this topical estrogen product. Since the approval of Evamist in 2007, the FDA has received eight reports of children between ages three and five who suffered adverse events including premature puberty, nipple swelling and breast development in females, and breast enlargement in males.

Small pets may be especially sensitive to the estrogen in Evamist. The FDA’s Center for Veterinary Medicine received two reports of secondary exposure in dogs, with such symptoms such as mammary/nipple enlargement and vulvar swelling.

The FDA warns patients using Evamist to prevent children and pets from touching the Evamist area of the arm, by wearing clothing that covers the skin if needed.

Evamist is not the only topical estradiol medication on the market. However, the FDA said it is unknown whether unintended exposure can occur with other topical estrogen products.