ARTICLE | Clinical News

EvaMist estradiol MDTS regulatory update

August 9, 2010 7:00 AM UTC

FDA issued a warning about inadvertent exposure of EvaMist to children and animals through skin contact that could result in adverse effects. Since the drug was approved in July 2007 through June 2010, FDA said it has received 8 reports of inadvertent exposure in children ages 3-5 that have resulted in premature puberty, nipple swelling and breast development in females, as well as breast enlargement in males. The agency also noted 2 cases of secondary exposure in dogs that have resulted in nipple enlargement and vulvar swelling. FDA plans to continue reviewing related reports. ...