FDA warns against exposure of children to Evamist

September 1, 2010

The FDA is warning that exposure to Evamist through skin contact with patients using the drug has the potential for adverse effects in children.

The FDA is warning that exposure to Evamist through skin contact with patients using the drug has the potential for adverse effects in children. Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm.

From July 2007 to June 2010, FDA received 8 postmarketing cases of unintended exposure to Evamist in children aged 3 to 5 years. Adverse events reported include premature puberty, nipple swelling, and breast development in girls, and breast enlargement in boys.

Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child's skin with soap and water as soon as possible if contact does occur. It is recommended that women wear a garment that covers the area where the drug was applied.