FDA approves drug for postmenopausal symptoms

October 10, 2013

The first drug combining estrogens with bazedoxifene has been approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate-to-severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.

 

The first drug combining estrogens with bazedoxifene has been approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate-to-severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.

Produced by Wyeth Pharmaceuticals, Duavee is indicated only for postmenopausal women who still have their uterus. Bazodoxifene reduces the risk of endometrial hyperplasia.

The FDA advises that clinicians prescribe Duavee for the shortest period of time that will meet treatment needs. It can be given solely to prevent osteoporosis, but the indication is only for women at serious risk of losing bone mass and strength and after careful consideration of other non-estrogen drugs.

Common adverse effects observed during clinical trials with estrogen plus bazedoxifene included muscle spasm, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, and neck pain. The drug will carry the same boxed warnings as other approved estrogen drugs.

 

 

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