FDA adds warning to prescription hot flash medication
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- Reviewed by Toni Golen, MD, Editor in Chief, Harvard Women's Health Watch; Editorial Advisory Board Member, Harvard Health Publishing; Contributor
The FDA has issued a "boxed warning" — its most prominent alert — noting that a relatively new, nonhormonal medication to reduce hot flashes and night sweats in menopausal women may cause rare but serious liver injury.
The warning, issued Dec. 16, 2024, highlights the risk that fezolinetant (Veozah) can cause liver injury, usually diagnosed by abnormally high liver blood test values. Approved by the FDA in May 2023, fezolinetant reduces the frequency and severity of hot flashes and night sweats — which affect an estimated 80% of women during menopause — by targeting specialized neurons in the brain's hypothalamus, which regulates body temperature. The drug blocks these nerve cells when dips in estrogen cause them to behave erratically, triggering hot flashes. Women who are taking the drug are supposed to have regular blood tests for liver function.
The FDA advises women who take fezolinetant to stop immediately and contact their doctor if they develop signs of liver problems. These include nausea, vomiting, unusual itching, light-colored stools, yellowing of the eyes or skin, dark urine, abdominal swelling, pain in the upper right abdomen, or feeling more tired than usual.
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About the Author
Maureen Salamon, Executive Editor, Harvard Women's Health Watch
About the Reviewer
Toni Golen, MD, Editor in Chief, Harvard Women's Health Watch; Editorial Advisory Board Member, Harvard Health Publishing; Contributor
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