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U.S. Department of Health and Human Services

Safety

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Vivelle-Dot (estradiol transdermal system)

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

 

May 2013

Summary View

BOX WARNING

  • updated text to reflect the current recommended estrogen-class labeling

CONTRAINDICATIONS

  • added ..... Known anaphylactic reaction or angioedema or hypersensitivity to Vivelle-Dot  
  • added .....Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

WARNINGS

  • added/changed subheadings and modified the accompanying text to reflect the current recommended estrogen-class labeling 

Malignant Neoplasm

Ovarian Cancer:

  • The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer.....

Hereditary Angioedema

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

PRECAUTIONS

  • updated to reflect current recommended estrogen-class labeling

ADVERSE REACTIONS

  • added postmarket experience section

PATIENT INFORMATION

  • Boxed Warning updated to include current recommended estrogen-class labeling