The FDA warns menopausal women using Evamist to avoid contact with children and pets

July 29, 2010|11:26 a.m.

The Food and Drug Administration on Thursday warned menopausal women using Evamist to avoid allowing children and pets to come into contact with the drug. Evamist contains the estrogen hormone estradiol and is sprayed on the forearms between the elbow and wrist to reduce hot flashes. The FDA said it has received eight reports of adverse effects from exposure to the drug in children ages 3 to 5, and two reports of problems with pets.

Young girls who came into contact with the drug reported symptoms of premature puberty, including development of breast buds and breast mass. Males developed symptoms of gynecomastia, an enlargement of the breasts. The symptoms developed several weeks to months after the adult patient began using Evamist.

The agency also received reports concerning two spayed female dogs that included signs of mammary/nipple enlargement and vulvar swelling. One dog suffered liver failure, and the second developed vaginal prolapse and elevated estrogen levels. They were exposed by licking the owner’s arm or by being held.

If children come into contact with the adult’s arms, the FDA said, they should immediately be washed with soap and water