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FDA Warns: This Hot Flash Medicine Can Cause Premature Puberty in Children

The U.S. Food and Drug Administration is warning that children exposed to a drug prescribed to menopausal women for hot flashes has the potential to cause premature breast development in girls, and breast enlargement in boys.

According to an FDA advisory, Evamist is a topical drug that contains estradiol, an estrogen hormone. It is sprayed on the skin between the elbow and wrist, on the inside of the forearm.

"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."

Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child's skin with soap and water as soon as possible if contact does occur, the FDA said.

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