Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- edited...Physicians are advised to discuss the content of the PATIENT INFORMATION leaflet and INSTRUCTIONS FOR USE with patients for whom they prescribe CombiPatch.
- added...Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.
- Revised general heading and two specific subheadings: Estrogen Plus Progestin Therapy and Estrogen-Alone Therapy
- Updated the text in the Boxed Warning to reflect the current recommended estrogen-class labeling
- Known anaphylactic reaction or angioedema or hypersensitivity to CombiPatch.
- Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
- added the following Sub-Headings: a. Stroke, b. Coronary heart disease, and c. Venous thromboembolism;
- modified the accompanying text to reflect the current recommended estrogen-class labeling.
- changed to reflect current recommended estrogen-class labeling
- Ovarian cancer and:
- 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 for CE plus MPA versus placebo was 1.58 (95 percent CI, 0.77-3.24). The absolute risk for CE plus MPA versus placebo was 4 versus 3 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen plus progestin and estrogen-only products, in particular for 5 or more years, has been associated with an increased risk of ovarian cancer. However, the duration of exposure associated with increased risk is not consistent across all epidemiologic studies and some report no association
- to reflect current recommended estrogen-class labeling
- Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema
- removed Ovarian cancer and removed the accompanying text.
- to reflect the findings in The Women’s Health Initiative Studies and The Women’s Health Initiative Memory Study;
- accompanying text was modified to reflect current recommended estrogen-class labeling
- added Postmarketing Experience sub-section and updated the accompanying text as appropriate.
PATIENT INFORMATION LEAFLET
- Updated the Boxed Warning to include current recommended estrogen-class labeling.
- “Who should not use CombiPatch?”
- “Have been diagnosed with a bleeding disorder”
- Modified “What are the possible side effects of CombiPatch?” to reflect current recommended estrogen-class labeling
PATIENT INFORMATION AND INSTRUCTION FOR USE
What should I tell my healthcare provider before I use CombiPatch?
- Before you use CombiPatch, tell your healthcare provider if you:
- “are going to have surgery or will be on bed rest"