FDA Advises Careful Use of Evamist

Not too long ago, a friend of mine told me that her puppies (PUPPIES!) went into heat, apparently as a result of their being exposed to the topical hormone cream that she was using on her lower arms.  It seemed odd to me and not worth writing about since, after all, how often does THAT happen?  Well, just over a week ago, the FDA issued a statement warning users of Evamist that this spray-on menopause treatment could indeed harm pets and children if they come in direct contact with it. Evamist contains estradiol, an estrogen hormone. It’s sprayed on the inside of the lower arm and is used to treat menopause-related hot flashes.  Since it was approved three years ago, the FDA has received eight reports of “adverse events” in children aged 3 to 5 who were unintentionally exposed to the drug. They define “adverse events” as premature puberty, nipple swelling and breast development in females and breast enlargement in males. Eight reports isn’t exactly a crisis, but I bet there are more unreported incidents of these “events” that cause a lot of worry, doctors appointments and unnecessary medical tests.

The FDA’s Center for Veterinary Medicine also has received two reports of dogs being exposed to Evamist and they cautioned that small dogs are at greater risk for estrogen sensitivity than larger ones.  One veterinarian I spoke with says that transference of topical hormones to pets is not as unusual as you think.  The Veterinary Information Network, a subscription web-based resource for veterinarians, compiled nearly twenty cases from around the nation of pets presenting with signs of estrogen excess, which according to a recently-published VIN article,  is manifested by labial enlargement in females and gynecomastia in males.  These symptoms go away when estrogen exposure to the pet is stopped.

The FDA statement includes helpful information for Evamist users.  If you want to report an adverse effect to Evamist, you can contact the FDA’s Medwatch program at 800-FDA-1088 or online on the Medwatch website .

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