Evamist Exposure May Spark Early Puberty in Children, FDA Warns

Federal drug safety regulators are warning that unintentional exposure to Evamist, a spray used to treat symptoms of menopause, may cause children as young as three years old to experience premature puberty. 

The FDA issued a drug safety communication on Thursday alerting healthcare professionals and patients that there have been cases where girls who were exposed to the hormonal spray experienced early breast development and boys who were exposed experienced breast enlargement. The FDA also warns that the spray has had hormonal side effects on pets as well.

Evamist (estradiol transdermal spray) is manufactured by Ther-Rx Corporation, a subsidiary of the KV Pharmaceutical Company, and approved in 2007 by FDA for the treatment of moderate-to-severe hot flashes. Evamist is applied by spraying it on the inside of the woman’s forearm between the elbow and the wrist. The spray contains an estrogen hormone.

According to the FDA, Evamist exposure through the skin for children has been found to cause nipple swelling and breast development in female children and breast growth in male children, a condition known as gynecomastia. The FDA has received reports of at least eight cases of children showing signs of premature puberty after exposure, ranging in age from three to five years old.

The symptoms appeared several weeks or months after the adult began using Evamist. In some cases, the symptoms went away after the adult stopped using Evamist or took extra steps to prevent Evamist exposure, but not all.

In pets, the side effects of Evamist exposure can cause mammary enlargement, elevated estrogen levels, vaginal prolapse, vulvar swelling, and liver failure. In the cases reported, the symptoms occurred after female dogs licked their owners’ arms.

The FDA says that it is still reviewing adverse event reports and attempting to determine contributing factors that lead to unintentional exposure, as well as how best to minimize Evamist premature puberty risk.

In the interim, the FDA recommends that patients using Evamist not allow children to make any contact with the area of the arm where Evamist was sprayed. If children do come into contact with the spray or sprayed skin, they should be washed with soap and water as soon as possible. If a child begins to show signs of early puberty after Evamist contact, notify a healthcare professional.

Pets should be prevented from licking or touching sprayed skin as well.

The FDA says that it does not know, at this time, whether other topical estrogen-based products could have the same effect and is continuing to investigate. Anyone who experiences Evamist side effects or who cares for a child who experiences premature puberty symptoms after Evamist exposure should contact FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch.