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FDA Approves Drug for Menopausal Women

Update Date: Oct 04, 2013 02:59 PM EDT

When women go through menopause, they might experience a wide range of symptoms as their bodies change. These symptoms, which include hot flashes and mood swings, can be very difficult to deal with. Fortunately, another drug that promises to treat hot flashes has entered the market. The U.S. Food and Drug Administration (FDA) just approved Pfizer Inc.'s Duavee.

Duavaee, which is a mix of estrogens and bazedoxifene, only needs to be taken once a day. According to Pfizer, Duavee should be prescribed to menopausal women who have not had a hysterectomy. It can also be taken by post-menopausal women to prevent osteoporosis. The drug was finally approved after the FDA examined the results from phase 3 clinical trials. One of these trials reported that women who took Duavee had a reduction in moderate-to-severe hot flashes by 74 percent just after 12 weeks. The women who took a placebo during this trial only had a 47 percent reduction.

Furthermore, Pfizer stated that women who took this pill also had increased levels of bone mineral density when compared to women who took placebos. The increases were seen in the hip and the lumbar spine around one to two years after treatment. Despite these positive results, there are side effects, which include muscle spams, diarrhea, nausea, abdominal pains, throat pain, dizziness and neck pain. Pfizer and medical experts stressed the importance of discussing the use of Duavee with one's doctor to determine if it is the right choice of treatment.

"Duavee should be used with caution, and only for the shortest time possible," said Dr. Jennifer Wu, an ob/gyn with Lenox Hill Hospital in New York City. "No hormone replacement is intended for the long term. Uterine cancer may still be a risk when using the estrogen. Longer term studies are needed."

The tablet will be available during the first quarter of 2014. The U.S. is the only country to have approved Duavee so far. 

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