FDA: Evamist Exposure Risky for Children
July 30, 2010 -- Doctors should advise women who use Evamist spray to prevent children from coming into contact with their medicated skin to avoid possible adverse events, such as premature puberty for girls and enlarged breasts for boys, according to the FDA.
Similar adverse events may occur in pets exposed to the drug.
Evamist is prescribed to reduce hot flashes in menopausal women. Those receiving the drug spray it on the inside of their forearm between the wrist and elbow. If patients cannot prevent a child from coming into contact with a patch of sprayed skin, they should wear a long-sleeved garment to cover the application site.
If children are exposed to the drug through skin contact, their skin should be washed with soap and water as soon as possible.
From the time Evamist was approved in July 2007 through June 2010, the FDA has received reports of eight cases of children aged 3 to 5 who were accidentally exposed to the drug. Girls experienced nipple swelling and breast development, and boys experienced breast enlargement.
These adverse events occurred several weeks to months after an adult began using the spray. With some cases, the problems resolved themselves once the adult stopped using the drug or took steps to prevent the children from touching medicated skin.
Slideshow: Menopause and Perimenopause Overview
Similar adverse events may occur in pets exposed to the drug.
Evamist is prescribed to reduce hot flashes in menopausal women. Those receiving the drug spray it on the inside of their forearm between the wrist and elbow. If patients cannot prevent a child from coming into contact with a patch of sprayed skin, they should wear a long-sleeved garment to cover the application site.
If children are exposed to the drug through skin contact, their skin should be washed with soap and water as soon as possible.
From the time Evamist was approved in July 2007 through June 2010, the FDA has received reports of eight cases of children aged 3 to 5 who were accidentally exposed to the drug. Girls experienced nipple swelling and breast development, and boys experienced breast enlargement.
These adverse events occurred several weeks to months after an adult began using the spray. With some cases, the problems resolved themselves once the adult stopped using the drug or took steps to prevent the children from touching medicated skin.
Slideshow: Menopause and Perimenopause Overview
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