July 30, 2010 -- Doctors should advise women who use Evamist spray to prevent children from coming into contact with their medicated skin to avoid possible adverse events, such as premature puberty for girls and enlarged breasts for boys, according to the FDA.
Similar adverse events may occur in pets exposed to the drug.
Evamist is prescribed to reduce hot flashes in menopausal women. Those receiving the drug spray it on the inside of their forearm between the wrist and elbow. If patients cannot prevent a child from coming into contact with a patch of sprayed skin, they should wear a long-sleeved garment to cover the application site.
If children are exposed to the drug through skin contact, their skin should be washed with soap and water as soon as possible.
From the time Evamist was approved in July 2007 through June 2010, the FDA has received reports of eight cases of children aged 3 to 5 who were accidentally exposed to the drug. Girls experienced nipple swelling and breast development, and boys experienced breast enlargement.
These adverse events occurred several weeks to months after an adult began using the spray. With some cases, the problems resolved themselves once the adult stopped using the drug or took steps to prevent the children from touching medicated skin.
The same precautions that apply to children and Evamist also apply to pets. The FDA has received reports of mammary and nipple enlargement, vulvar swelling, and liver failure in one female dog exposed to the drug, and vaginal prolapse and elevated estrogen levels in a second female dog.
"Small pets may be especially sensitive to the estrogen in Evamist," the agency states in a consumer bulletin.
The FDA is studying reports of adverse events in children and pets associated with the drug and is working with the manufacturer to identify any factors that may contribute to unintended exposure.
More information about the announcement is available on the FDA's web site.
To report adverse events related to Evamist, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 800-FDA-1088 or online at www.fda.gov/medwatch.