THURSDAY, July 29 (HealthDay News) -- Evamist, a drug used to
reduce menopause-related hot flashes in women, may harm children
and pets who have skin contact with the drug, the U.S. Food and
Drug Administration said Thursday.
The product, which is sprayed on the skin between the elbow and
wrist and on the inside of the forearm, contains an estrogen
hormone called estradiol. Evamist was approved for use in the
United States in 2007.
Since then, the FDA has received eight reports of adverse events
in children aged 3 to 5 who were unintentionally exposed to the
drug. The adverse events include: premature puberty, nipple
swelling and breast development in females; and breast enlargement
In addition, the FDA's Center for Veterinary Medicine has
received two reports of dogs being exposed to Evamist. This may
lead to mammary/nipple enlargement and swelling of the vulvus.
"Women using Evamist need to be aware of the potential risks to children who come into contact with the area of skin where this drug is applied," Dr. Julie Beitz, director of the FDA's Office of Drug Evaluation, said in an agency news release.
"It is important that people know to keep both children and pets away from the product to minimize exposure," she added.
Women who use Evamist should prevent children from touching the
area of the arm where the product is sprayed. If a child does touch
this area, wash the child's skin with soap and water as soon as
possible, the FDA advised.
Do not let pets lick or touch the area where Evamist is applied.
Small pets may be especially sensitive to the estrogen in the
If it's difficult to prevent children or pets from direct
contact with areas of the skin where Evamist is applied, women
should wear a garment that covers the area.
Currently, it is not known whether unintended exposure can occur
with other estrogen products that are applied to the skin, the FDA
Any side effects believed to be caused by Evamist should be
reported to FDA's MedWatch Adverse Reporting program at
The National Women's Health Information Center has more about