Evamist Menopause Spray May Harm Children and Pets: FDA

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.

Women Using Spray Must Take Precautions

While experts say it's wise for to warn consumers about exposure to estrogen, there's not enough information available yet to sound the alarm about life-threatening consequences.

"I wouldn't expect a single, acute exposure to be a reason for concern," said Casavant.

"If you stop the exposure, the breast tissue regresses," said Haymond, referring to other cases of estrogen exposure and not Evamist.

They advise women to continue using Evamist if their doctor recommends it, but take precautions when around children or pets. The spray is applied to the inside of the forearms daily, according to a company video.

"If you become aware of a single, accidental exposure, ask where they've had that contact. Just touching the skin doesn't necessarily result in instantaneous absorption, so you can go ahead and wash the skin," said Casavant.

The FDA also recommends that pets not be allowed to lick the areas where the drug was applied, and if direct contact with the area sprayed with Evamist can't be avoided, women should cover it with clothing.

But if at all possible, women should use it when children and animals are not around.

"The best level of exposure is zero exposure," said Landrigan.