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Label Changes for:

Evamist (estradiol transdermal spray)

March 2014

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

March 2014

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

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

 

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