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FDA Approves New Treatment for Hot Flashes 

The first-of-its-kind pill gives another option to women going through menopause

spinner image Veozah drug product packaging and pill tablet
Astellas Pharma via AP Newsroom

The estimated 80 percent of women who get hot flashes when going through menopause have a new option to help them get some relief. The treatment is a drug called Veozah, just approved by the U.S. Food and Drug Administration (FDA).

Menopause typically occurs between the ages of 45 and 55. Sudden hot flashes, often accompanied by sweating, flushing and chills, can persist for many years and disrupt daily life. Research shows that these flares can affect quality of sleep and concentration. They can also interfere with one's ability to work, according to a new study published in Mayo Clinic Proceedings

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“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, M.D., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, in a statement. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

How the drug works

The first-of-its-kind pill — called a neurokinin 3 (NK3) receptor antagonist — works by acting on a part of the brain that helps regulate a person's body temperature. Estrogen helps to keep that part of the brain properly balanced. When a woman's estrogen levels fall during menopause, the imbalance leads to hot flash symptoms.  

“It’s very targeted,” Claudia Mason, M.D., a gynecologist with Cleveland Clinic, says about the new drug. “And when things are targeted like that, they tend not to have as many side effects because they’re not hitting all over the map.”

In clinical trials, moderate to severe hot flashes were reduced in study participants who took Veozah (fezolinetant). Common side effects of the drug include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases (liver enzymes).

The label on the medication, a pill taken once daily with or without food, includes a warning for liver injury, and the FDA says patients should have their blood tested for liver damage before taking Veozah.

The treatment, from drugmaker Astellas Pharma, is expected to cost $550 for a one-month supply. How much people will pay out of pocket will depend on their insurance coverage.


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Expanding treatment options

This new medicine is the latest in a tool kit of treatments for hot flashes.

One alternative is hormone therapy. However, not all women are good candidates for hormones, including those with a history of blood clots, heart attack and stroke.

Mason says Veozah could be an option for them. “We have loads of women that are going through menopause every single day, and so options are always good.” However, she notes that unlike hormone therapy, this new medication does not treat other symptoms caused by menopause, like vaginal discomfort.

The FDA has also approved an antidepressant, paroxetine, to treat hot flashes. And Mason anticipates more treatments will become available.

The National Institute on Aging notes that some lifestyle changes can help to reduce hot flash symptoms, such as avoiding alcohol, spicy foods and caffeine, which can make menopausal symptoms worse. Research shows that mindfulness meditation may also be used to help manage hot flashes.

Video: How to Tame a Hot Flash

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