Inadvertent exposure to Evamist through skin contact with women using this product has the potential for adverse effects in children and pets, warns the Food and Drug Administration (FDA).
Evamist contains estradoil, an estrogen hormone, which is sprayed on the forearms between the elbow and wrist to help reduce hot flashes during menopause.
The FDA is reviewing reports of adverse events. So far, the agency is aware of eight reports of adverse effects from exposure to the drug in children ages 3 to 5. Two reports involved pets.
Adverse events reported in children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males.
“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.”
For more information regarding the warning, refer to the FDA News Release.
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