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Warning About Topical Menopause Drug
(July 30, 2010) - The Food and Drug Administration (FDA) is warning about a drug for hot flashes, called Evamist. Inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets, according to FDA.
Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. (Read about "Menopause") The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.
"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," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "It is important that people know to keep both children and pets away from the product to minimize exposure."
Evamist was FDA approved in 2007. From July 2007 to June 2010, 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. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA's Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.
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. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed as small pets may be especially sensitive to the estrogen in this product. If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.
Note: Statements and conclusions of study authors that are published here are solely those of the study authors and do not necessarily reflect this hospital's policy or position. This hospital makes no representation or warranty as to their accuracy or reliability.
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