The US Food and Drug Administration (FDA) has approved a novel estrogen-based drug for women for the treatment of moderate-to-severe vasomotor symptoms and osteoporosis associated with menopause. Duavee (Wyeth Pharmaceuticals) is a once-a-day tablet containing a combination of conjugated estrogens and bazedoxifene, an estrogen agonist/antagonist.
How Does Duavee Differ from Other Estrogen Preparations for Menopausal Women?
Duavee contains bazedoxifene, an estrogen agonist/antagonist substitute for the progestins used in other preparations, such as Prempro. It reduces the risk of endometrial hyperplasia, a possible precursor to cancer associated with unopposed estrogen.
Is it Safer?
The FDA advises clinicians to prescribe the new drug “for the shortest duration consistent with treatment goals and risks”, which is what is suggested for other estrogen-containing products. Duavee will come with the same warnings that appear on the labels of previously approved estrogen products.
The most common side effects reported were muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness and neck pain.
More information is available on the FDA website.
Ruta Nonacs, MD PhD
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