Evamist Menopause Spray May Harm Children and Pets: FDA
A topical hot flash treatment may also pose problems for pets, the FDA warns.
July 30, 2010 -- Getting rid of your hot flashes may be harmful to children and pets around you.
The U.S. Food and Drug Administration is warning that exposure to Evamist, a spray used to control hot flashes during menopause, may be associated with early puberty and early breast development in young children. The FDA reports that there were eight children between the ages of three and five who experienced premature puberty, nipple swelling, breast development and breast enlargement after "unintended exposure" to Evamist. According to an FDA spokesperson, "unintended exposure" likely means casual contact, such as hugging.
The FDA says they also received reports of two dogs who were exposed to Evamist, though they did not elaborate on the symptoms those animals exhibited. In general, the agency says that signs include mammary or nipple enlargement and swelling of the vulva.
K-V/Ther-Rx, the manufacturer of Evamist, told ABC News in an e-mail that they "proposed taht the product labeling for Evamist be updated accordingly. K-V/Ther-Rx is continuing to work proactively with the FDA to ensure that patients and healthcare providers are aware of the potential risk of estrogen transfer to children and pets, as well as steps that can be taken to mitigate this risk."
Evamist's main ingredient is estrogen, and one of the functions of estrogen is to help breasts develop. Since Evamist contains estrogen, experts say these cases make sense, and the effects are similar to those seen in children exposed to other estrogen-containing products, such as birth control pills.
"We commonly get calls about people who get into estrogen products that aren't prescribed for them," said Dr. Marcel Casavant, the medical director of the Central Ohio Poison Center at Nationwide Children's Hospital in Columbus, Ohio. "Often, they're children who get exposed to oral contraceptives."
While it's unknown how much of the product the eight children who were reported by the FDA were exposed to, experts say exposure to even small amounts of estrogen can trigger breast development.
"It depends on the concentration of estrogen, but it could be that small amounts are enough to turn on the cells that lead to breast development," said Dr. Morey Haymond, professor of pediatrics at Baylor College of Medicine.
"Estrogen is a very powerful chemical, so even a little bit of exposure can go a long way," said Dr. Philip Landrigan, director of the Children's Environmental Health Center at the Mount Sinai School of Medicine.
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