Safety Alerts & Recalls
What does this mean?
Women using Evamist need to be aware of the potential risks of premature puberty in children who come in contact with the area of skin where this drug is applied. If you use Evamist, it is important to keep both children and pets away from the product to minimize exposure.
The FDA has provided the following recommendations to women using the Evamist product:
- Do not allow children to make contact with the area of the arm where Evamist was sprayed. If contact with children cannot be avoided, it is recommended that you wear a garment with long sleeves to cover the application site.
- If a child comes in direct contact with the arm where Evamist was sprayed, wash the child's skin with soap and water as soon as possible.
- Contact the child's healthcare professional if the child begins to have any of the following signs or symptoms: nipple or breast swelling or breast tenderness in females, or breast enlargement in males. Be sure to tell the healthcare professional that the child may have been exposed to Evamist.
- If you are using Evamist and have questions concerning the possibility of drug transfer to a child, you should consult your healthcare professional.
- Do not allow pets to lick or touch the arm where Evamist was sprayed. Small pets may be especially sensitive to the estrogen in Evamist. Contact your pet's veterinarian if your pet exhibits signs of nipple and/or vulvar enlargement, or any other signs of illness.
- Read the Patient Package Insert when picking up a prescription for Evamist.
You can report any side effects from the use of Evamist or any other medicine to the FDA MedWatch program by phone at 1-800-332-1088; by fax at 1-800-332-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch
The FDA Announces Ongoing Safety Review of Evamist and Reports of Unintended Exposure of Children and Pets
The Food and Drug Administration (FDA) says children and pets should not be exposed to Evamist, a drug for women that is sprayed on the skin to treat hot flashes caused by menopause. The FDA is reviewing reports of adverse effects from Evamist, an estrogen hormone. Children unintentionally exposed to the drug through skin contact with women may experience premature puberty. Female children may experience nipple swelling and breast development. Male children may experience breast enlargement. The FDA has also received reports of accidental exposure in pets. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and swelling of the genitals.
Evamist contains the estrogen hormone estradiol. It is sprayed inside the forearm between the elbow and wrist. Consumers should take precautions to prevent children and pets from making contact with skin where Evamist has been sprayed.
The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures with Evamist. The FDA will update the public when this review is complete.
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