The Food & Drug Administration (FDA) has notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist, an estrogen hormone used to reduce hot flashes during menopause. The product is sprayed on the skin between the elbow and wrist, and as such it can have unintended contact with young children and pets. The FDA is working with the company to identify any factors that may contribute to unintended exposure. The Agency will update the public when this review is complete.
Between July 2007 and June 2010, the FDA received eight cases of children aged 3 and 5 years old being unintentionally exposed to the topical estrogen product Evamist. Affected children suffered from adverse reactions, including premature puberty, nipple swelling and breast enlargement. And since 2007, there have been two reports of exposure to the product in dogs. According to the FDA, affected pets will exhibit similar reactions to children who have been exposed to the product.
The FDA has recommended that patients make sure that children and pets are not exposed to Evamist or come into contact with any skin or hair where the drug was applied. Women who cannot avoid contact should wear a garment with long sleeves to cover the application site. Any adverse events or side effects can be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.