Label Changes for:
Vivelle-Dot (estradiol transdermal system)
Changes have been made to the BOXED WARNING, 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)
- updated text to reflect the current recommended estrogen-class labeling
- 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
- added/changed subheadings and modified the accompanying text to reflect the current recommended estrogen-class labeling
- 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.....
- Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema
- updated to reflect current recommended estrogen-class labeling
- added postmarket experience section
- Boxed Warning updated to include current recommended estrogen-class labeling