-- Robert Preidt
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."
The U.S. Office on Women's Health has more about
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