CNN
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The US Food and Drug Administration on Friday approved a new class of medication to treat hot flashes and night sweats during menopause.
Veozah, or fezolinetant, made by Astellas Pharma, is the first neurokinin 3 (NK3) agonist. It blocks receptors in the brain that play a role in regulating body temperature. It is an alternative to traditional hormone replacement therapies to control hot flashes, which are a common symptom of menopause that can be harmful if they become severe.
Women at increased risk of stroke, heart attack, or some types of cancer are sometimes advised not to use hormone replacement therapies because they increase the risk of blood clots and cancers.
“Hot flashes as a result of menopause can be a serious physical burden for women and affect their quality of life,” said Dr. Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the Drug Center. Evaluation and Investigation, in a Press release. “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.”
Menopause is a normal period in a woman’s life that usually begins in her mid to late 40s. During menopause, the body produces less estrogen and progesterone. The gradual reduction of these hormones can trigger sleep interruptions, mood swings, and hot flashes: periods of sweating, hot flashes, and chills that can last several minutes.
In clinical trials involving more than 3,000 women in the US and Canada, Veozah reduced the number of hot flashes women experienced each week significantly more than placebo. The studies followed women who took the drug for a year.
Veozah comes with a warning about the risk of liver damage. The FDA says that women who are considering taking it should have blood tests to make sure they don’t have any liver damage or infection before they start taking the drug, and they should be checked with blood tests every three months to make sure they don’t show signs of liver damage while taking the medicine.
The most common side effects reported in the studies were abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver enzymes.
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