FDA OKs drug to treat hot flashes in menopausal women

October 4, 2013
FDA OKs drug to treat hot flashes in menopausal women
Clinical trials also showed some protection against bone loss; blood clots are a risk

(HealthDay)—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 , 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 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 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 ; 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 should weigh their options carefully before choosing to take the .

"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."

Explore further: FDA approves drug for older women experiencing painful sex

More information: The U.S. Office on Women's Health has more about menopause.

Related Stories

FDA approves drug for older women experiencing painful sex

February 26, 2013
(HealthDay)—The U.S. Food and Drug Administration has approved a new drug to treat postmenopausal women who experience pain during sex, the agency announced Tuesday.

Pfizer breast cancer drug gets breakthrough label

April 10, 2013
Pfizer Inc. says its experimental pill for advanced, often deadly breast cancer has been designated as a breakthrough therapy by the Food and Drug Administration.

First non-hormonal remedy approved for menopausal hot flashes

July 1, 2013
(HealthDay)—Brisdelle (paroxetine) has been approved by the U.S. Food and Drug Administration as the first non-hormonal treatment to treat hot flashes associated with menopause.

For women with hysterectomies, estrogen may be a lifesaver after all

July 18, 2013
The widespread rejection of estrogen therapy after the 2002 Women's Health Initiative (WHI) study has most likely led to almost 50,000 unnecessary deaths over the last 10 years among women aged 50 to 69 who have had a hysterectomy, ...

Estrogen helps keep joint pain at bay after hysterectomy

March 20, 2013
Estrogen therapy can help keep joint pain at bay after menopause for women who have had a hysterectomy. Joint pain was modestly, but significantly, lower in women who took estrogen alone than in women who took placebo in ...

New hormone therapy shows promise for menopausal symptoms in animal model

December 13, 2012
Investigators at Wake Forest Baptist Medical Center have concluded research on a new postmenopausal hormone therapy that shows promise as an effective treatment for menopausal symptoms and the prevention of osteoporosis without ...

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.