Evamist_0710

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					          Consumer Health Information
          www.fda.gov/consumer




Keep Kids, Pets Away From
Skin Sprayed With Evamist
T
     he Food and Drug                      • not allow children to come
     Administration (FDA) says               in contact with the area of
     children and pets should not            the arm where Evamist was
                                             sprayed
be exposed to Evamist, a drug
                                           • not allow pets to lick
for women that is sprayed on the             or touch the arm where
skin to treat hot flashes caused             Evamist was sprayed. Small
by menopause.                                pets may be especially
                                             sensitive to the estrogen
  The agency also wants consumers to         in Evamist. Contact a
take precautions to ensure that children     veterinarian if your pet
and pets do not make contact with skin       shows signs of nipple and/or
where Evamist has been sprayed.              vulvar enlargement, or any
  Evamist contains the estrogen hor-         other sign of illness
mone estradiol. It is sprayed inside the   • wear a garment that covers
forearm between the elbow and wrist.         the arm where Evamist was
  FDA, which issued its warning on           sprayed if they know they
July 29, 2010, says it is reviewing          cannot keep a child or pet
reports of adverse events in children        from making contact with it
and pets who were inadvertently            • talk with their health
exposed to Evamist.                          care professional if they have          MedWatch Adverse Event Report-
  Adverse events reported in unin-           questions about the possibility of      ing Program
tentionally exposed children include         exposing a child to Evamist             • Online (www.fda.gov/MedWatch/)
• premature puberty, nipple swelling,      • read the patient package insert         • Regular Mail: Use postage-paid,
  and breast development in girls            when picking up a prescription            pre-addressed FDA form 3500
• breast enlargement in boys                 for Evamist                             • Fax: 1-800-FDA-0178
                                                                                     • Phone: 1-800-332-1088
  FDA has also received reports of         If Contact Occurs
inadvertent exposure in pets. Pets         If a child comes in contact with the        At this time, it is unknown whether
exposed to Evamist may exhibit             part of the arm where Evamist was         unintended exposure can occur with
signs such as mammar y/nipple              sprayed, FDA recommends                   other topical (applied to the skin)
enlargement and vulvar swelling.           • washing the child’s skin with soap      estrogen products.
  “Women using Evamist need to be            and water as soon as possible             FDA continues to review adverse
aware of the potential risks to children   • contacting the child’s health care      event reports and evaluate ways to
who come in contact with the area of         professional if the child begins to     reduce unintended exposures.
skin where this drug is applied,” says       have any of the following signs
Julie Beitz, M.D., a director of drug        or symptoms: nipple or breast
evaluation with FDA. “It is important        swelling or breast tenderness in          Find this and other Consumer
that people know to keep both chil-          girls, or breast enlargement in           Updates at www.fda.gov/
dren and pets away from the product          boys. Be sure to tell the health care     ForConsumers/ConsumerUpdates
to minimize exposure.”                       professional that the child may
                                             have been exposed to Evamist                      Sign up for free e-mail
Advice for Consumers                                                                   subscriptions at www.fda.gov/
FDA recommends t hat women                   You can report any side effects           consumer/consumerenews.html
using Evamist                              from the use of Evamist to FDA’s

1 / FDA Consumer Health Information / U.S. Food and Drug Administration                                          J U LY 2 0 1 0

				
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posted:3/10/2012
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