Evamist Exposure May Spark Early Puberty in Children, FDA Warns

Federal drug safety regulators are warning that unintentional exposure to Evamist, a spray used to treat symptoms of menopause, may cause children as young as three years old to experience premature puberty. 

The FDA issued a drug safety communication on Thursday alerting healthcare professionals and patients that there have been cases where girls who were exposed to the hormonal spray experienced early breast development and boys who were exposed experienced breast enlargement. The FDA also warns that the spray has had hormonal side effects on pets as well.

Evamist (estradiol transdermal spray) is manufactured by Ther-Rx Corporation, a subsidiary of the KV Pharmaceutical Company, and approved in 2007 by FDA for the treatment of moderate-to-severe hot flashes. Evamist is applied by spraying it on the inside of the woman’s forearm between the elbow and the wrist. The spray contains an estrogen hormone.

Did You Know?

Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

According to the FDA, Evamist exposure through the skin for children has been found to cause nipple swelling and breast development in female children and breast growth in male children, a condition known as gynecomastia. The FDA has received reports of at least eight cases of children showing signs of premature puberty after exposure, ranging in age from three to five years old.

The symptoms appeared several weeks or months after the adult began using Evamist. In some cases, the symptoms went away after the adult stopped using Evamist or took extra steps to prevent Evamist exposure, but not all.

In pets, the side effects of Evamist exposure can cause mammary enlargement, elevated estrogen levels, vaginal prolapse, vulvar swelling, and liver failure. In the cases reported, the symptoms occurred after female dogs licked their owners’ arms.

The FDA says that it is still reviewing adverse event reports and attempting to determine contributing factors that lead to unintentional exposure, as well as how best to minimize Evamist premature puberty risk.

In the interim, the FDA recommends that patients using Evamist not allow children to make any contact with the area of the arm where Evamist was sprayed. If children do come into contact with the spray or sprayed skin, they should be washed with soap and water as soon as possible. If a child begins to show signs of early puberty after Evamist contact, notify a healthcare professional.

Pets should be prevented from licking or touching sprayed skin as well.

The FDA says that it does not know, at this time, whether other topical estrogen-based products could have the same effect and is continuing to investigate. Anyone who experiences Evamist side effects or who cares for a child who experiences premature puberty symptoms after Evamist exposure should contact FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch.

2 Comments

  • nancyFebruary 23, 2012 at 12:13 am

    i just found out 2 weeks ago from my ob/gyn dr. that there had been a warning issed only because it quit working for me and i needed to change to something else. we have spent aproximately $3000.00 in the last 2 years on our 5 year old yorkie that was spaded before she was a year old, trying to find out why she looked like she had had two litters of puppies and she only weighed 5 pounds at that ti[Show More]i just found out 2 weeks ago from my ob/gyn dr. that there had been a warning issed only because it quit working for me and i needed to change to something else. we have spent aproximately $3000.00 in the last 2 years on our 5 year old yorkie that was spaded before she was a year old, trying to find out why she looked like she had had two litters of puppies and she only weighed 5 pounds at that time, 6 pounds now. she has been to va. tech 2 times, once for a surgery to see if our vet had left a ovarian remnant in her that re-attached and started to grow again, he had not. i started on the evamist in november, 2009, pennie started having issues around july 2010 with very enlarged nipples and a very enlarged vulva. i have been off the evamist for 2 weeks now and her symptoms are not reversing yet but she is more active, eats better, plays more, sleeps less. i cannot imagin how she has felt for at least 2 1/2 years and if she is having withdrawal symptoms now and long term liver damage.the report was issued in 2010. how did all the information fall thur the cracks for so long. i know she is just a pet but to us she is a chiild. i cannot imagine if she was a male or female real child. what else can we do now to help? we take her tomorrow to have her teeth cleaned and the vet wants to see all my information in order to see if there is somekind of lab work he can do to see what damage if any has been done to her. i myself have not had any damage that i know of except that the evamist just quit working for me. i was using 2 sprays a day and did not want to start using the 3 sprays a day my doctor said i could. figured it would just be better to go on something else, which i did.

  • MarySeptember 14, 2010 at 2:43 pm

    Everyone should be aware that the drug Evamist IS very harmful to your children. As of June 2010, I have 2 Grandchildren that has all the side effects from this so called medicine. My 2 year old Granddaughter has started her period along with the enlarged breast and her 3 year old brother has the enlarged breast. SO PLEASE BE AWARE IF YOU ARE TAKING THIS MEDICINE OR IF YOUR DOCTOR TRYS TO PRESCRIB[Show More]Everyone should be aware that the drug Evamist IS very harmful to your children. As of June 2010, I have 2 Grandchildren that has all the side effects from this so called medicine. My 2 year old Granddaughter has started her period along with the enlarged breast and her 3 year old brother has the enlarged breast. SO PLEASE BE AWARE IF YOU ARE TAKING THIS MEDICINE OR IF YOUR DOCTOR TRYS TO PRESCRIBE THIS MEDICINE. They have been seen by a specialist and have alot more treatment to be done.

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories