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FDA: Avoid unintentional exposure of children, pets to estrogen spray
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The FDA has issued a warning about inadvertent exposure to Evamist — the only FDA-approved estrogen therapy spray — in children and pets, and is currently reviewing reports of adverse events at this time.
“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,” Julie Beitz, MD, director of the FDA’s Office of Drug Evaluation III, said in a press release. “It is important that people know to keep both children and pets away from the product to minimize exposure.”
Originally approved in 2007, Evamist is sprayed on the skin between the elbow and wrist, on the inside of the forearm.
Between July 2007 and June 2010, the FDA received eight postmarketing reports of inadvertent exposure in children, aged 3 to 5 years, including premature puberty, nipple swelling, breast development in girls and breast enlargement in boys.
Since 2007, two reports of inadvertent exposure in pets also occurred, including signs of mammary enlargement and vulvar swelling.
The FDA recommends for women using the drug to:
- Not allow children to come in contact with the area of the arm where Evamist is sprayed.
- Not allow pets to lick or touch the arm where the drug is sprayed.
- Wear a garment that covers the arm where the drug is sprayed if they know they cannot keep a child or pet from coming in contact with it.
- Talk with their health care professional if they have questions about the possibility of exposing a child to the drug.
- Read the patient package insert when picking up a prescription for Evamist.
The FDA will continue to review adverse event reports and evaluate ways to reduce unintended exposures to these products. At this time, it is unknown whether unintended exposure can occur with other topical estrogen products.
Consumers and health care professionals should report any side effects by using the FDA’s MedWatch Adverse Event Reporting program.
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