The U.S. Food and Drug Administration has issued a warning about rare but serious liver injury associated with Veozah (fezolinetant), a non-hormonal medication approved for treating moderate to severe hot flashes related to menopause. The agency is requiring updates to the drug’s prescribing information to include this new safety information, advising healthcare providers and patients to monitor for signs of liver problems and to discontinue the medication immediately if liver injury is suspected.
Veozah, manufactured by Astellas Pharma, was approved in May 2023 as the first neurokinin 3 receptor antagonist for managing vasomotor symptoms of menopause. The medication works by targeting brain pathways involved in temperature regulation, offering an alternative for women who cannot or prefer not to use hormone replacement therapy. Since its approval, the FDA has identified cases of serious liver injury among patients taking the medication, prompting this safety update.
The warning emphasizes that patients should stop taking Veozah and contact their healthcare provider immediately if they experience symptoms that may indicate liver damage. These symptoms include yellowing of the skin or whites of the eyes (jaundice), dark-colored urine, nausea and vomiting, loss of appetite, pain in the upper right side of the abdomen, unusual tiredness, or easy bruising or bleeding. Healthcare providers are advised to conduct liver function tests before starting treatment and to monitor patients who develop concerning symptoms.
This development is significant for the millions of women experiencing menopausal hot flashes who seek alternatives to traditional hormone therapy. While Veozah has provided an important new treatment option, particularly for women with contraindications to estrogen therapy, this warning underscores the importance of careful monitoring and individualized risk-benefit assessment. Patients currently taking Veozah should not stop their medication without consulting their healthcare provider, but should remain vigilant for any signs of liver problems and report them immediately.
