Label Changes for:
Estring (estradiol vaginal ring)
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)
- *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.*
- Known anaphylactic reaction or angioedema or hypersensitivity to Estring …
- Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.
- 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.*
- *updated to reflect current recommended estrogen-class labeling.*
- Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.
- *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*
- *addition of Cases of Hypersensitivity