ST LOUIS (MD Consult) - On July 29, 2010, the US Food and Drug Administration (FDA) issued a notice regarding a safety concern related to the use of Evamist (estradiol transdermal spray). The FDA has received reports of inadvertent exposure to the product by children and pets.

Evamist was approved by the FDA in July 2007. From that time through June 2010, the FDA has received 8 postmarketing cases of unintended exposure of children to Evamist. The children ranged in age from 3 to 5 years.

Young girls who are exposed to the product may experience signs and symptoms of premature puberty and breast development. Gynecomastia may develop in boys who have been exposed to Evamist. Pets exposed to the product may experience mammary/nipple enlargement and vulvar swelling.

Evamist is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist. It is used by women to reduce hot flashes during menopause.

Children should not be allowed to make contact with the area of the arm where Evamist was sprayed. If contact with children cannot be avoided, it is recommended that a garment with long sleeves be worn to cover the application site. If a child comes in direct contact with the arm where Evamist was sprayed, the child's skin should be washed with soap and water as soon as possible. The child's health care professional should be contacted if signs of exposure become evident.

Pets should not be allowed to lick or touch the arm where Evamist was sprayed. Small pets may be especially sensitive to the estrogen in Evamist. Patients should be advised to contact a veterinarian if a pet exhibits signs of nipple and/or vulvar enlargement or any other signs of illness.

圣路易斯(MD Consult)——2010年7月29日，美国食品药品管理局(FDA)发布了一则与使用Evamist(雌二醇透皮喷剂)有关的安全性通告。FDA已收到有关儿童和宠物意外暴露于此药的报告。

Evamist于2007年7月获得FDA的批准。从那时起直至2010年6月，FDA已收到8例儿童意外暴露于Evamist的上市后病例，其年龄介于3~5岁。

年幼的女孩暴露于该药品后可出现性早熟和乳房过早发育的症状和体征。男孩暴露于Evamist后会发生男性乳房发育征。宠物暴露于此药后会出现乳房或乳头增大及外阴肿胀。

Evamist是一种局部用药，喷洒在肘腕部之间前臂内侧的皮肤上，用于减少女性更年期潮热。

应避免孩子接触Evamist喷洒区皮肤。若无法避免孩子接触，则建议穿长袖衫覆盖用药区。若孩子直接接触Evamist喷洒区皮肤，则尽快使用肥皂清洗孩子接触区皮肤。若出现暴露相关的体征，则联系医护专业人员进行处置。

应避免宠物舔舐或接触Evamist喷洒区。小型宠物对Evamist中的雌激素尤为敏感。应建议患者在宠物出现乳头和(或)乳房增大或其他任何患病征象时联系兽医进行处置。