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FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen

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Welcome, my name is Mary Kremzner, a pharmacist in the Division of Drug Information. I am informing you about FDA's ongoing safety review of adverse event reports in children who may have been unintentionally exposed to the drug through skin contact with women using Evamist. FDA has also received reports of inadvertent exposure in pets.

Evamist was approved by FDA in July 2007. Since then through June 2010, FDA has received 8 postmarketing cases of unintended exposure of children to Evamist. The children ranged in age from three to five years.

Evamist (estradiol), an estrogen hormone, is used in women to reduce hot flashes during menopause. It is a sprayed on the skin on the inside of the forearm between the elbow and the wrist.

The reported adverse events were consistent with premature puberty in female children such as nipple swelling and breast development, including development of breast buds and breast mass. For males, reported adverse events were consistent with gynecomastia or breast enlargement. The signs and symptoms appeared several weeks to months after the adult patient initiated therapy with Evamist. Some cases reported symptom resolution after the Evamist user discontinued the drug or used preventive measures to avoid unintentional exposure of children to the drug.

Reports of secondary exposure to Evamist in two spayed female dogs have been received by FDA's Center for Veterinary Medicine since 2007 and include signs of mammary or nipple enlargement, vulvar swelling, and liver failure in one case, and vaginal prolapse and elevated estrogen levels in the other. In both cases, secondary exposure occurred through licking of the owner's arms or by the dog being held by the owner.

FDA does not have information to assess the potential of topical Evamist transfer from adult users to children. It is not feasible to conduct such studies.

Moreover, FDA is currently reviewing these reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure, as well as evaluating ways to minimize unintended exposures with Evamist.

FDA recommends thatHealthcare Professionals:

  1. Be aware that unintentional exposure by children to Evamist can result in signs and symptoms of premature puberty and breast development in females, as well as gynecomastia in males.
  2. Advise patients to cover the application site if direct contact with children or pets cannot be avoided. If a child comes in direct contact with the arm where Evamist was sprayed, wash the child's skin with soap and water as soon as possible.
  3. Continue to counsel patients on how to apply Evamist properly.
  4. Encourage patients to read the Patient Package Insert when picking up their prescription for Evamist. Make certain patients know they should not expose children to Evamist and that children do not come into contact with any skin area where the drug was applied. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site.
  5. Be aware that inadvertent exposure to Evamist was reported in household pets and alert patients to this potential. Advise patients not to allow pets to lick or touch the arm where Evamist was sprayed. Small pets may be especially sensitive to the estrogen in Evamist. Have patients contact their pet's veterinarian if the pet exhibits signs of nipple and/or vulvar enlargement, or any other signs of illness.
  6. Report adverse events involving Evamist to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. If you have questions about this safety communication, you can reach the Division of Drug Information at the following email address: druginfo@fda.hhs.gov.



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