Exposure to Estradiol Transdermal Spray Risky for Children and Pets, FDA Says

Disclosures

July 29, 2010

July 29, 2010 — Physicians should advise women who use estradiol transdermal spray (Evamist; Ther-Rx) to prevent children from coming into contact with their medicated skin to avoid possible adverse events such as premature puberty for girls and enlarged breasts for boys, the US Food and Drug Administration (FDA) announced today.

Similar adverse events may happen to pets exposed to the drug.

Estradiol transdermal spray is prescribed to reduce hot flashes in menopausal women. Those receiving the drug spray it on the inside of their forearm between the wrist and elbow. If patients cannot prevent a child from coming into contact with a patch of sprayed skin, they should wear a long-sleeved garment. If children are exposed to the drug through skin contact, they should be washed with soap and water as soon as possible.

From the time estradiol transdermal spray was approved in July 2007 through June 2010, the FDA has received reports of 8 cases of children ages 3 to 5 years who were accidentally exposed to the drug. Girls experienced nipple swelling and breast development, and boys experienced breast enlargement. These adverse events occurred several weeks to months after an adult began using the spray. With some cases, the problems resolved themselves once the adult stopped using the drug or took steps to prevent the children from touching medicated skin.

Small Pets May Be More Sensitive to Spray Than Large Ones

The same precautions that apply to children and estradiol transdermal spray also apply to pets. The FDA has received reports of mammary and nipple enlargement, vulvar swelling, and liver failure occurring in 1 female dog exposed to the drug, and vaginal prolapse and elevated estrogen levels in a second female dog.

"Small pets may be especially sensitive to the estrogen in Evamist," the agency stated in a consumer health bulletin.

The FDA is studying reports of adverse events in children and pets associated with the drug and is working with the manufacturer to identify any factors that may contribute to unintended exposure.

More information about today's announcement is available on the FDA's Web site.

To report adverse events related to estradiol transdermal spray, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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