Sprayed-On Estradiol May Transfer to Children, Pets

Cheryl A. Thompson

BETHESDA, MD 29 July 2010—FDA announced today that it is reviewing reports of premature puberty in young girls, gynecomastia in young boys, and other adverse events in pets unintentionally exposed to estradiol transdermal spray.

The labeling for the product, marketed as Evamist by Ther-Rx Corporation, does not instruct users to cover the inner forearm—the recommended site of application—after spraying on a dose.

But FDA, in its drug safety communication, is advising patients to wear a garment with long sleeves if there is no way to prevent children from coming in contact with the area of the arm where the estradiol spray was applied.

Patients, FDA added, should not allow pets to lick or touch the application site.

The transdermal spray treats moderate to severe hot flashes and other vasomotor symptoms due to menopause.

A study conducted in support of the application to market Evamist found no significant transfer of estradiol from women to men one hour after application. The study, described in the product's labeling, involved 20 healthy postmenopausal women who sprayed Evamist three times on an inner forearm. One hour later, the women held that forearm against the inner forearm of a man continuously for five minutes.

FDA said it has received reports on eight children, ages 3–5 years old, whose unintended exposure to estradiol transdermal spray resulted in symptoms of premature puberty or gynecomastia.

The agency also received reports describing two spayed dogs with signs of estradiol exposure. One dog had licked her owner's arms, and the other dog was exposed by being held by her owner.

A similar situation arose a year ago with testosterone gels. At the time, FDA said most of those secondary exposures in children occurred because the patients did not follow instructions in the products' labeling to wash their hands after applying the gel and cover the application site with clothing.