FDA: Evamist Tied to Adverse Effects in Children, Pets

Agency warns women using estradiol transdermal spray to minimize children's, pets' exposure
By Beth Gilbert
HealthDay Reporter

FRIDAY, July 30 (HealthDay News) -- The U.S. Food and Drug Administration has warned that unintentional exposure to estradiol transdermal spray (Evamist) through skin contact with patients using the spray may cause adverse effects in children and pets.

Estradiol transdermal spray is used for the treatment of hot flashes in women during menopause and is applied to the skin between the elbow and wrist, on the inside of the forearm. The FDA issued the warning after receiving eight post-marketing reports of unintentional exposure to estradiol transdermal spray in children 3 to 5 years of age between July 2007 and June 2010. In addition, two reports of secondary exposure to estradiol transdermal spray in dogs were received by the FDA's Center for Veterinary Medicine since the drug's FDA approval in 2007.

In children, adverse events reported include breast enlargement in males and premature puberty, nipple swelling, and breast development in females. In addition, pets may experience mammary or nipple enlargement and vulvar swelling.

"Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied," Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III, said in a statement. "It is important that people know to keep both children and pets away from the product to minimize exposure."

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