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November 18, 2021 – The U.S. FDA is expanding a black box warning, the most prominent warning that can be required on a drug label, for Bayer's Climara Pro® (estradiol/levonorgestrel) transdermal patch. Climara Pro is used to treat the symptoms of menopause and prevent postmenopausal osteoporosis.
- The black box warning now cautions there is an increased risk of endometrial cancer in women with a uterus who use estrogen without the addition of progestin. Climara Pro contains both an estrogen (estradiol) and a progestin (levonorgestrel).
- Climara Pro also has black box warnings for cardiovascular disorders, dementia, and breast cancer.
- For treatment of menopause symptoms, Climara Pro should be used at the lowest effective dose and for the shortest duration possible. To prevent osteoporosis, Climara Pro has a recommended dose of one patch containing estradiol 0.045mg and levonorgestrel 0.015mg applied once weekly.
- The U.S. FDA first approved Climara Pro in 2003.