Evamist Dangers Remind Us to Keep Medications Away from Children and Pets

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The FDA has issued a Drug Safety Communication to healthcare providers and patients regarding the menopause treatment Evamist, a transdermal spray containing an estrogen hormone. Unintentional exposure to the drug can cause possible adverse events to children and pets and should be kept out of reach.

Evamist estradiol transdermal spray, manufactured by Ther-Rx Corporation, was introduced in July 2007 and approved for use in menopausal women to reduce hot flashes. Those receiving the drug spray it on the inside of their forearm between the wrist and elbow.

The FDA has received reports of 8 cases of children ages 3 to 5 years who were accidentally exposed to the drug. Girls experienced signs of premature puberty, such as nipple swelling and breast development, and boys experienced breast enlargement (gynecomastia). These adverse events occurred several weeks to months after an adult began using the spray.

For most children, the symptoms went away after the adult stopped using Evamist or took extra steps to prevent exposure.

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The agency has also received reports of mammary and nipple enlargement, vulvar swelling, and liver failure occurring in 1 female dog exposed to the drug. A second dog experienced vaginal prolapsed and elevated estrogen levels. In both cases, the dogs licked their owner’s arms. Smaller pets appear to be especially sensitive, said the FDA in a consumer health bulletin.

The FDA is recommending that patients using Evamist estradiol transdermal spray to avoid exposing children with the area of the arm where the medication was sprayed. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site. If children do come into contact with the spray or sprayed skin, they should be washed with soap and water as soon as possible. Pets should be prevented from licking or touching sprayed skin as well.

The FDA says that it does not know, at this time, whether other topical estrogen-based products could have the same effect and is continuing to investigate. But any adult who takes any kind of medication should be careful to keep them away from children at all times. The National Safety Council offers these suggestions:

• Never leave medicine out. Keep all medications in a securely latched medicine cabinet, even if you don't think your child can reach it.
• Always store medications in their original containers with child-resistant lids, and make sure the containers are securely closed.
• Try not to take medication in front of children, and never act like they are candy or something to play with.
• When you dispose of medications, don't just throw them in the garbage can. Dispose of them in a way that a child can't find and swallow them.

*To report adverse events related to estradiol transdermal spray, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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