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FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of childre

Posted Jul 29 2010 11:56am

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary

Safety Announcement

[07-29-2010] The U.S. Food and Drug Administration (FDA) is reviewing reports of adverse effects from Evamist in children who may have been unintentionally exposed to the drug through skin contact with women using this product. FDA has also received reports of inadvertent exposure in pets.

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

Patients should make sure that children are not exposed 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.

Children unintentionally exposed to Evamist may experience premature puberty. Female children may experience nipple swelling and breast development. Male children may experience breast enlargement.

Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.

FDA is currently reviewing these reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure. FDA and the company are also evaluating ways to minimize the risk.

This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The Agency will update the public when this review is complete.

Additional Information for Patients 

  • Do not allow children to make contact with the area of the arm where Evamist was sprayed. If contact with children cannot be avoided, it is recommended that you wear a garment with long sleeves to cover the application site.
  • 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.
  • Contact the child's healthcare professional if the child begins to have any of the following signs or symptoms: nipple or breast swelling or breast tenderness in females, or breast enlargement in males. Be sure to tell the healthcare professional that the child may have been exposed to Evamist.
  • If you are using Evamist and have questions concerning the possibility of drug transfer to a child, you should consult your healthcare professional.
  • Do not allow pets to lick or touch the arm where Evamist was sprayed. Small pets may be especially sensitive to the estrogen in Evamist. Contact your pet's veterinarian if your pet exhibits signs of nipple and/or vulvar enlargement, or any other signs of illness.
  • Read the Patient Package Insert when picking up a prescription for Evamist.
  • Report any side effects from the use of Evamist to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Additional Information for Healthcare Professionals  

  • 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.
  • Advise patients to cover the application site if direct contact with children or pets cannot be avoided.
  • Continue to counsel patients on how to apply Evamist properly.
  • Encourage patients to read the Patient Package Insert when picking up their prescription for Evamist.
  • Be aware that inadvertent exposure to Evamist was reported in household pets and alert patients to this potential.
  • Report adverse events involving Evamist to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.

Data Summary  

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.

The reported adverse effects were consistent with premature puberty in females, including development of breast buds and breast mass. For males, reported adverse effects were consistent with gynecomastia. 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/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.

FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures with Evamist.

    
 

Contact Us

  • Report a Serious Problem

  • 1-800-332-1088
  • 1-800-FDA-0178 Fax
  • MedWatch Online

    Regular Mail: Use postage-paid FDA Form 3500

    Mail to: MedWatch 5600 Fishers Lane

    Rockville, MD 20857

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