The Food and Drug Administration is warning women who use Evamist (an estrogen product sprayed on the skin to treat hot flashes) that inadvertent contact with small children might cause premature puberty.
The FDA said it has gotten eight reports of adverse events after children aged 3 years to 5 years were exposed to the hormone from skin to skin contact with women who had sprayed it on their arms. The medication is sprayed on the skin on the inside of the.
“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, director of the FDA’s office of drug evaluation.
Reports of adverse events related to children’s exposure include nipple swelling and early breast development in girls, and breast enlargement in boys. The FDA is recommending that women who use the product and cannot avoid contact with young children should wear clothing that fully covers the area in order to reduce the risk of exposure.
If contact does occur, the FDA advises washing the area of contact as quickly as possible with soap and water.
The agency is also investigating potential adverse events connected with pets exposed to the drug which contains estradiol, an estrogen hormone.
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