Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Vaginal erosion, vaginal ulceration, adherence of the vaginal ring to the vaginal wall:
- Cases of ring adherence to the vaginal wall, making ring removal difficult, have occurred. Some cases have required surgical removal of vaginal rings.
- Cases of vaginal erosion and vaginal ulceration that may manifest as vaginal irritation, erythema, abrasion or spotting have occurred.
- Vaginal wall ulceration or erosion should be carefully evaluated. If an ulceration or erosion has occurred, consideration should be given to leaving the ring out and not replacing it until healing is complete in order to prevent the ring from adhering to the healing tissue.
- *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