Skip to content

    Menopause Health Center

    Font Size
    A
    A
    A

    FDA OKs Drug to Treat Hot Flashes in Menopausal Women

    Clinical trials also showed some protection against bone loss; blood clots are a risk

    WebMD News from HealthDay

    By Robert Preidt

    HealthDay Reporter

    FRIDAY, Oct. 4 (HealthDay News) -- Pfizer Inc. says it has gained U.S. approval for a drug designed to treat menopause-related hot flashes and potentially prevent osteoporosis in postmenopausal women who have a uterus.

    The United States is the first country to approve the once-a-day tablet called Duavee (conjugated estrogens/bazedoxifene), according to Pfizer. When prescribed just for the prevention of osteoporosis in postmenopausal women, use of Duavee should only be considered for women at significant risk, and non-estrogen medication should be considered first, the drug maker advised.

    The U.S. Food and Drug Administration's approval was based on phase 3 clinical trials that included generally healthy, postmenopausal women with a uterus. One study found that women taking the drug had 74 percent fewer moderate-to-severe hot flashes after 12 weeks of treatment, compared with a 47 percent reduction among women who took a placebo, Pfizer said in a news release.

    In other trials, women who took Duavee showed increased levels of bone mineral density in the hip and lumbar spine after one and two years of treatment, while women in the placebo group had decreased levels, the drug company said.

    Common side effects of Duavee include muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness and neck pain, according to Pfizer.

    Pfizer said that Duavee should not be used by women who: have or have had blood clots; are allergic to any of its ingredients; have unusual vaginal bleeding; have or have had certain cancers (e.g. uterine or breast), liver problems, or bleeding disorders; or are pregnant, may become pregnant or are breast-feeding.

    Estrogen and drugs like bazedoxifene can increase the risk of blood clots. Women should talk with their doctor about how long to stay on Duavee, Pfizer said.

    One expert said women should weigh their options carefully before choosing to take the drug.

    "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," Wu added. "Longer term studies are needed."

    Today on WebMD

    woman walking outdoors
    How to handle headaches, night sweats, and more.
    mature woman holding fan in face
    Symptoms and treatments.
     
    woman hiding face behind hands
    11 ways to keep skin bright and healthy.
    insomnia
    Is it menopause or something else?
     
    senior couple
    Video
    mature woman shopping for produce
    Article
     
    Alcohol Disrupting Your Sleep
    Article
    mature couple on boat
    Article
     
    mature woman tugging on her loose skin
    Slideshow
    senior woman wearing green hat
    Article
     
    estrogen gene
    Quiz
    supplements
    Article
     

    WebMD Special Sections