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FDA Drug Safety Podcast: Avoid Unintentional Exposure of Children and Pets to Evamist

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On July 30, 2010, the Food and Drug Administration (FDA) issued a drug safety communication about the unintentional exposure of children and pets to Evamist.

I am Yolanda Fultz-Morris from F-D-A's Center for Drug Evaluation and Research.

FDA is issuing this advisory to warn that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.

Evamist contains an estrogen hormone used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. FDA is currently reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.

Evamist was FDA approved in 2007. From July 2007 to June 2010, FDA received eight reports of unintended exposure to Evamist in children ages 3 years to 5 years. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs have been received by FDA's Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.

Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed. If contact does occur, wash the child's skin with soap and water as soon as possible. Pets should not lick or touch the arm where Evamist is sprayed; small pets may be especially sensitive to the estrogen in this product. If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.

At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.

We urge healthcare providers and patients to report any side effects from Evamist by using the FDA's MedWatch Adverse Event Reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.

 

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