FDA WARNING About Evamist Estrogen Spray

When it comes to battling hot flashes due to menopause, physicians have an arsenal of hormone replacement products to choose from, including pills, skin patches, creams, and a topical prescription spray called Evamist. This estrogen product is sprayed on the inside of the forearm, between the elbow and the wrist. Dosage is one, two, or three applications per day.

Today, the U.S. Food and Drug Administration (FDA) issued a warning to keep children and pets from being exposed to skin treated with Evamist. That mean no hugs for kids, grandkids, or pets unless the forearms are covered by long sleeves.

According to the FDA, some adverse effects caused by unintentional exposure to the drug include:

• premature puberty, nipple swelling, and breast development in girls
• breast enlargement in boys.
• pets may also experience mammary/nipple enlargement.

“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,” says Julie Beitz, M.D., a director of drug evaluation with FDA. “It is important that people know to keep both children and pets away from the product to minimize exposure.” (From FDA consumer advice)

WHAT TO DO

The FDA recommends that women using Evamist take special care to keep children and pets from coming into contact with the product–even if the drug seems totally absorbed into your forearm, it can still potentially be active and transferable. Always wear long sleeves if you cannot keep a child or pet away, and never allow a pet to lick your forearm.

If you believe a child has come into contact with a part of your arm where Evamist was sprayed, the FDA recommends:

• Wash the child’s skin with soap and water as soon as possible;
• Contact the child’s health care professional if the child begins to have any of the following signs or symptoms: nipple or breast swelling or breast tenderness in girls, or breast enlargement in boys. Be sure to tell the health care professional that the child may have been exposed to Evamist;
• Talk with your doctor about possible alternative treatments if the risk of exposing others is high.
• You can report any side effects from the use of Evamist to FDA’s MedWatch Adverse Event Reporting Program online or by mail, fax, or phone.
  o Fax: 1-800-FDA-0178
  o Phone: 1-800-332-1088

Here’s a question we have that wasn’t answered in any of the FAQs: If this product can exert hormonal effects on adult women (to whom it is prescribed), girls, boys, and pets… does it have an effect on adult men? Are there any potential side effects to watch for if a woman in his life uses Evamist? Perhaps breast enlargement or erectile dysfunction? Just asking.

We looked on the website for Evamist, including the full prescribing information, and we couldn’t find any information that might suggest that these types of adverse effects are possible for children. The most the package insert says is “keep out of reach of children.” That’s a whole lot different from “don’t hug your grandkids or risk premature puberty.”

We are appalled that this product may have put children in hormonal danger, without a single warning. HensonFuerst will be keeping our investigative eyes open on this. If you have used this product and have questions about how to report adverse effects in a child, contact our office at 919-781-1107, or the FDA at the numbers above.