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A New Warning for Evamist
by admin on: April 25th, 2011

Evamist is the proprietary name for an estradiol-based transdermal spray. This drug is indicated to treat women who present with moderate to severe vasomotor symptoms (so-called ???hot flushes???) that are associated with the onset and occurrence of menopause. Menopause is a natural, biological process that occurs in all women, and is generally recognized as the permanent end of menstruation and fertility. Generally speaking, a woman is considered to have entered menopause approximately one year after her last period. The onset of menopause results in a number of hormonal changes that are often associated with emotional changes.

Recent evidence submitted to the U.S. Food and Drug Administration (FDA) prompted the FDA to release a warning regarding the use of this product. Evamist, as mentioned above, is a spray on product. The typical area women spray this drug is on their skin between their elbow and wrist. As such, it is possible that this drug, soon after application, may come in contact with other people or pets; reports have indicated that unintentional or inadvertent exposure to Evamist has the potential to produce adverse effects in pets and children.

Since Evamist was approved in 2007, the FDA has been made aware of eight post-marketing cases where Evamist was exposed to children between the ages of three to five years. The adverse effects reported included premature puberty, nipple swelling, and breast development in females, as well as breast enlargement in males. There have also been two cases where dogs were exposed to Evamist (unintentionally) and the adverse effects reported included mammary/nipple enlargement and vulvar swelling. Should children come into contact with this drug, their skin should be immediately washed with soap and water. Pets should also be kept away from the area sprayed, and if this proves difficult, the FDA recommends that women wear a garment covering their skin that was exposed to this drug. For further information on this topic, please consult the FDA’s website (www.fda.gov).

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