FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause

FDA reviewed a postmarketing case of serious drug-induced liver injury that occurred in a patient who received Veozah to treat menopausal hot flashes caused. Before starting Veozah, the patient’s liver blood test levels were normal. Within 40 days of starting it, several liver blood test values were significantly elevated: alanine transaminase, more than 10 times of normal level; alkaline phosphatase, more than four times of normal level; and total bilirubin, more than 3 times of normal level. The patient reported symptoms of liver injury, including fatigue, nausea, decreased appetite, itching of hands and feet that later spread to the entire body, jaundice, pale feces, and dark urine. The patient’s prescriber found no abnormalities when checking for other causes of liver injury, using ultrasonography of the liver and blood tests for viral hepatitis. With discontinuation of Veozah, the signs and symptoms gradually resolved, and liver blood test values returned to normal. We concluded this patient had liver injury as a result of Veozah treatment.