Label Changes for:

Estring (estradiol vaginal ring)

August 2014

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

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

 

August 2014

BOXED WARNING

  • *Updated the Boxed Warning to include a revised general heading and two specific subheadings: Estrogen-Alone Therapy and Estrogen Plus Progestin Therapy; updated the text in the Boxed Warning to reflect the current recommended estrogen-class labeling.*

CONTRAINDICATIONS

  • Known anaphylactic reaction or angioedema or hypersensitivity to Estring …
  • Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.

WARNINGS

Cardiovascular Disorders-Stroke
  • Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women receiving CE (0.625 mg)-alone versus those receiving placebo (18 versus 21 per 10,000 women-years).
Cardiovascular Disorders - Coronary Heart Disease
  • Subgroup analyses of women 50 to 59 years of age suggest a statistically nonsignificant reduction in CHD events (CE [0.625 mg]-alone compared to placebo) in women with less than 10 years since menopause (8 versus 16 per 10,000 women-years).
Malignant Neoplasms-Breast Cancer
  • *updated to reflect the current recommended estrogen-class labeling.*
Probable Dementia
  • *updated to reflect current recommended estrogen-class labeling.*
Hereditary Angioedema
  • Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.

PRECAUTIONS

Geriatric Use
  • *updated to reflect the findings in The Women’s Health Initiative Studies and The Women’s Health Initiative MemoryStudy; accompanying text was modified to reflect current recommended estrogen-class labeling.*
  • *Updated PRECAUTIONS Section to reflect current recommended estrogen-class labeling*

ADVERSE REACTIONS

Postmarketing Experience
  • *addition of Cases of Hypersensitivity

PATIENT INFORMATION

  • *Updated*
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