The Food and Drug Administration on July 29 warned physicians and patients that children exposed to a mist form of estradiol might experience hormonally fueled side effects such as breast enlargement.
The topical estrogen, Evamist, is sprayed on the skin on the inside of the forearm.
The FDA said that, since Evamist was approved in 2007, the agency has received eight reports in children aged 3-5 years who had been exposed to the drug through skin contact. The girls experienced premature puberty, including development of breast buds and breast mass, while the boys reported effects consistent with gynecomastia, the agency said in a safety announcement.
These effects occurred several weeks to several months after the adult relative had started Evamist therapy. In some cases, symptoms resolved after the estrogen was discontinued or when the child’s exposure was minimized.
The agency also said that it had received exposure reports in two spayed female dogs that had licked the Evamist users’ forearm. One animal experienced mammary/nipple enlargement, vulvar swelling, and liver failure, and the other had vaginal prolapse and elevated estrogen levels.
The FDA is working with Evamist maker Ther-Rx to identify factors contributing to the exposures.