Pets that have inadvertent exposure to the human topical estrogen product, Evamist, may experience adverse effects, according to the U.S. Food and Drug Administration.
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.
Since 2007, when Evamist was FDA approved, the FDA’s Center for Veterinary Medicine has received two reports of secondary exposure to the product in dogs. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling, according to the FDA.
The FDA is warning pet owners that animals should not be allowed to lick or touch the arm where Evamist is sprayed. If direct contact cannot be avoided, the FDA recommends that women wear a garment that covers the area where the drug was applied.
The product should also be kept away from children, according to the FDA. From July 2007 to June 2010, the FDA received eight post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males.
The FDA noted that it is currently unknown if unintended exposure can occur with other topical estrogen products. The FDA said it is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.
The FDA is asking consumers and health care professionals to report any side effects from Evamist by using the FDA’s MedWatch Adverse Event Reporting program: call 800-332-1088 or visit www.fda.gov/medwatch.