The Food and Drug Administration (FDA) has approved a new drug, conjugated estrogen with bazedoxifene (Duavee), to treat hot flashes related to menopause and to prevent osteoporosis in women who've not undergone hysterectomy. It is the first such drug that combines estrogen with an estrogen agonist–antagonist.
The estrogen agonist–antagonist (bazedoxifene) reduces the risk of endometrial hyperplasia, which can occur with estrogen replacement, because it has an antagonist effect on estrogen receptors in the uterus. However, because of its estrogen component, Duavee's labeling carries the same warnings and precautions that accompany other estrogen products: endometrial cancer; cardiovascular disorders, including blood clots, stroke, and myocardial infarction; and “probable” dementia (defined in trials as Alzheimer's disease, vascular dementia, or a mixed form). These warnings are based on findings from the landmark Women's Health Initiative. Like other estrogen products, Duavee is recommended only for short-term use, and postmenopausal women should be assessed periodically to determine whether use of the drug is still warranted. As with other estrogen products, its use for the prevention of osteoporosis should be limited to women at significant risk and only after nonestrogen drugs have been considered.
Duavee is taken orally daily. The most common adverse effects are muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, and neck pain. Nurses working with patients taking Duavee should note that the drug carries the same risks that are associated with other estrogen therapies (except that the risk of endometrial hyperplasia is diminished). As they would do with any patient prescribed estrogen products, nurses should assess the patient prescribed Duavee for contraindications to use: a history of breast or uterine cancer, unusual vaginal bleeding, a history of venous thrombosis or pulmonary embolism, thrombotic diseases (such as stroke or myocardial infarction), bleeding disorders, or liver problems. Patient education should be similar to that provided with other estrogen products, including instructions to report any pain in the legs, bleeding, vision changes, abdominal pain, shortness of breath, or vaginal bleeding to the prescriber.
Complete FDA prescribing information can be found at http://1.usa.gov/18ajlpu.