A recent Food and Drug Administration (FDA) MedWatch Safety Alert warns women to make sure children and pets do not come into contact with Evamist that they have sprayed on their skin.    Evamist is a transdermal spray containing estradiol, a form of estrogen. It is sprayed inside of the forearm between the elbow and wrist to reduce hot flashes during menopause. Each squirt of spray delivers 90 mcL which contains 1.53 mg of estradiol and is FDA approved for this use.

The FDA has received reports of side effects in children who were unintentionally exposed to Evamist.   Side effects include:

  • nipple swelling and breast development in girls
  • Breast enlargement in boys

FDA has also received reports of unintentional exposure in pets, which may show signs of mammary/nipple enlargement and vulvar swelling.

The FDA recommends that you do not allow children to come in contact with area of the arm where Evamist was sprayed.  If a child is exposed to Evamist, wash the child's skin with soap and water as soon as possible.      Contact the child's health professional if nipple or breast swelling or breast tenderness occurs in girls, or breast enlargement occurs in boys.    Do not allow pets to lick or touch the arm where Evamist was sprayed.   Small pets may be especially sensitive to Evamist.   Contact a vet if your pet shows any signs of illness, including enlargement of the nipples or vulva.

Women who use Evamist should wear clothing that covers the arm sprayed with the drug if they cannot prevent accidental contact.

The FDA

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Comments

Thank you for this very informative article. The FDA very rarely gets involved (too rarely) in determining toxicity for dogs - especially because among dog breeds there is such an incredibly wide range of sizes and weights -- a toxicity level for a Chihuahua may have next to no effect on a Great Dane, for example.

Thanks for the info..FDA really has its handful these days because of the new drugs coming out each and everytime. Sometimes the side effects don't show up for years. FDA really has to keep up with technology even though they have tight budgets!

best if you know who or where your kids are going to prevent them from getting in contact with evamist, specially young children who are always getting carried

It would be nice if there could be more testing of side effects of products done that included children and pets not just the intended user. I am also to going back to natural ways of dealing with illnesses, but I know that is a long way from happening on a grad scale.

That is some serious warning! How should we break this to grandma in a nice way? It makes me wonder what it really does to the woman using it if it is that dangerous to kids and pets. We will probably find out in a few years from now...

The FDA takes a lot of heat for some questionable calls on certain drugs. However, if people will give them the benefit of the doubt they do a great job of saving us from a lot of harm. Glad they got this one right.

That explains it. I have a male and female toy poodle and noticed nipple swelling for both of them. It all started 3 days after my mom started evamist on her underarm. I thought it was a food allergy but never something serious. Now it all make sense and as early as this week, I'll have my Tom and Gerry checked by their Vet. Now, I'm worried.As soon as they're all set, I'll have them registered as companion dogs via the website I found but I'm still crossing my fingers. Thanks for the post

Menopause covers a large number of women in the US, which also means a lot of children and a lot of pets. Thanks for the heads up on this product. It is great to have the warning and information on the dangers of Evamist. I'm wondering how this product ever made it to market with these adverse kinds of effects. Does anyone know how long this has been on the market, and how effective it is in assisting women with menopause?

Thanks for the post it is really very informative. It's good that the FDA gave out this warning before more children and pets will be harmed by the drug.

Thank you for this post. Thats all I are able to say. You most absolutely have built this blog website into something speciel. You clearly know what you are working on, youve insured so many corners.thanks

Very informative post thanks for sharing it..It was nice that FDA gave out this warning. FDA really great because of the new drugs coming out each and everytime. Sometimes the side effects don’t show up for years. <

FDA approval process ensures that items in connection with food items &amp; beverage, makeup and professional medical device are safe used as well as the product labels show the actual ingredients as well as doesn't make false claims.

Keeping all medications, including transdermal ones away from children and animals is crucial. Too often I see the negative results of a dog ingesting some medication. Please keep your medications locked and away from kids and pets. And when in doubt call 911 or for your pet go to the animal hospital.

Thank you for this important information. Never thought about it before. I will be more cautious in the future.

I put some ASDA path and patio weedkiller down at 6pm last night in the garden. It came in sachets and I diluted it as instructed. It said to keep children and pets away. When will it be safe for the children to play out again?

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