FDA Issues Drug Safety Communication for Evamist (estradiol transdermal spray)
Published: Jul 30, 2010
The Food and 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. Children unintentionally exposed to the drug through skin contact with women may experience premature puberty. Female children may experience nipple swelling and breast development. Male children may experience breast enlargement.
Evamist is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist. The FDA is currently reviewing reported adverse events and 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. FDA and the company are also evaluating ways to minimize the risk.
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