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U.S. Department of Health and Human Services

Safety

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Evamist (estradiol transdermal spray)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

March 2014

Summary View

CONTRAINDICATIONS

  • Known anaphylactic reaction or angioedema
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

WARNINGS AND PRECAUTIONS

Hereditary Angioedema
  • Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.

ADVERSE REACTIONS

Postmarketing Experiences
  • Skin: Nipple and areola discoloration, usually on the same side of the body as the inner forearm on which Evamist is applied, rash, pruritus, alopecia, urticaria, dry skin, skin discoloration, chloasma 

 

October 2011

Summary View

BOXED WARNING

  • Unintentional secondary exposure........added

 

WARNINGS AND PRECAUTIONS

Unintentional Secondary Exposure to Estrogen.....added

 

PATIENT COUNSELLING INFORMATiON

Unintentional Secondary Exposure to Estrogen...added

 

PATIENT PACKAGE INSERT

  • extensive changes re: unintentional secondary exposure to estrogen