(September 30, 2010)
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Evamist (estradiol), an estrogen hormone, is used in women to reduce hot flashes during menopause. It is a sprayed on the skin on the inside of the forearm between the elbow and the wrist. Evamist was approved by FDA in July 2007. Since then through June 2010, FDA has received 8 postmarketing cases of unintended exposure of children to Evamist.
The reported adverse events were consistent with premature puberty in female children such as nipple swelling and breast development, including development of breast buds and breast mass. For males, reported adverse events were consistent with gynecomastia or breast enlargement. The signs and symptoms appeared several weeks to months after the adult patient initiated therapy with Evamist. Some cases reported symptom resolution after the Evamist user discontinued the drug or used preventive measures to avoid unintentional exposure of children to the drug.
FDA is currently reviewing these reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure, as well as evaluating ways to minimize unintended exposures with Evamist.