We’re at the U.S. Food and Drug Administration with the Division of Drug Information pharmacists. Today they are discussing an ongoing safety review of Evamist and unintended exposure of children to topical estrogen. This is FDA Drug Info Rounds, a program by pharmacists for pharmacists.
Did you see the recent announcement about Evamist, the topical estrogen spray used in women to reduce hot flashes during menopause?
Yeah, I did. It said that FDA was reviewing reports of adverse events in children who had been unintentionally exposed to estrogen through skin contact with women who were using Evamist.
The reported adverse events included some signs and symptoms of premature puberty in children.
Evamist was approved by the FDA in 2007. Between initial marketing and June 2010, the agency became aware of 8 postmarketing cases of unintended exposure of children to Evamist. The children in the reports ranged from 3 to 5 years old.
The reported adverse events were consistent with premature puberty in females including development of breast buds and breast mass, and gynecomastia in males. The signs and symptoms appeared several weeks to months after the adult patient started treatment with Evamist. Some cases reported symptom resolution after Evamist was discontinued or preventive measures to avoid unintentional exposure of children were taken.
FDA is continuing to review these reported adverse events to identify any factors that may have contributed to unintended exposure. FDA and the company are also evaluating ways to minimize this risk.
This is a great opportunity for pharmacists to make an impact by counseling women on how to appropriately use Evamist and advise them on ways to mitigate the risk of unintentional exposure to children.
You are absolutely right Brenda. Pharmacists should tell patients who use Evamist that:
Children should not make contact with any skin area where Evamist was applied. If contact with children cannot be avoided, they should wear a garment with long sleeves that covers the application site.
Pharmacists should also advise patients that if a child does come into contact with that area, the child’s skin should be washed with soap and water as soon as possible.
Additionally, pharmacists should encourage patients to read the patient package insert when picking up their prescription for Evamist. This will help them understand the potential risks of using Evamist.
Those are good recommendations, Chris. Patients should also be instructed to contact the child’s healthcare professional if the child begins to have nipple or breast swelling, tenderness, or breast enlargement.
I also saw that adverse events in animals had been reported to FDA, too.
Interestingly enough, that’s true. Because FDA also received reports of adverse events in animals, it is important to advise women using Evamist that they should not allow pets to lick or touch the arm where they sprayed Evamist.
If their pet starts to show signs of being “in heat”, swollen nipples, or swelling of the vulvar area in female pets, they should contact their veterinarian.
We want to ensure that both children and animals are not unintentionally exposed to Evamist.
Thanks for joining the FDA pharmacists at their Drug Info Rounds. This is our FDA program of pharmacists helping pharmacists educate consumers, so they can make better medication choices.
To report medication adverse events call 1-800-332-1088 or go online to www.fda.gov/medwatch.
If you have any questions, you may reach FDA’s Division of Drug Information by calling 1-888-463-6332 or email us at firstname.lastname@example.org.