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FDA Alert Regarding Adverse Effects in Children After Unintentional Exposure to Evamist
FDA advises patients and health care providers of reports regarding adverse effects from Evamist® in children who may have been unintentionally exposed to the drug through skin contact with women using this product. Evamist contains estradiol, an estrogen hormone, and is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist. Children unintentionally exposed to Evamist may experience premature puberty. FDA is currently reviewing these reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure and to evaluate ways to minimize the risk. FDA advises that patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was applied, and for those who cannot avoid contact with children to wear a garment with long sleeves to cover the application site. Additional information for patients is provided in an FDA Drug Safety Communication.
