FDA approves Duavee to treat hot flashes and prevent osteoporosis

[10-3-2013] The U.S. Food and Drug Administration today approved Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause.

Duavee is the first FDA approved medication that combines estrogen with an estrogen agonist/antagonist (bazedoxifene). The bazedoxifene component of Duavee reduces the risk of endometrial hyperplasia (excessive growth of the lining of the uterus) that can occur with the estrogen component of Duavee.

Duavee is intended only for postmenopausal women who still have a uterus. Like other products containing estrogen, Duavee should be used for the shortest duration consistent with treatment goals and risks for the individual woman. When using Duavee only for the prevention of osteoporosis, such use should be limited to women who are at significant risk of osteoporosis after carefully considering alternatives that do not contain estrogen.

The most common side effects observed in patients receiving Duavee were muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, and neck pain. Because Duavee contains estrogen, it is being approved with the same Boxed Warning and other Warnings and Precautions that have been approved with estrogen products.

Duavee is marketed by Wyeth Pharmaceuticals, Inc. (a subsidiary of Pfizer Inc.,) based in Philadelphia, Pa.

Note: The FDA approval of Duavee is an activity that is funded under FDA's user fee program in the Center for Drug Evaluation and Research (CDER). Some excepted FDA activities that do not rely on annual appropriations are continuing during the government shutdown.

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