HQ Team
September 13, 2024: The U.S. Food and Drug Administration (FDA) has issued a safety warning about Veozah (fezolinetant), a medication prescribed for treating moderate to severe hot flashes during menopause, as it can potentially cause serious liver injuries.
This warning was made following a postmarketing report of a patient with elevated liver blood test values and signs and symptoms of liver injury after taking the medicine for about 40 days. The FDA has also added an advisory of frequent blood tests after one starts the medicine.
Veozah
The regulatory body recommends stopping the medicine immediately if patients show any signs of liver injury such as nausea; vomiting; unusual itching; light-colored stools; yellowing of the eyes or skin; dark urine; or swelling in the stomach or belly area.
Veozah (fezolinetant) is a nonhormonal prescription medicine approved in 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. It works to restore the balance between estrogen hormones and a brain chemical called neurokinin B (NKB) by blocking the activities of the NK3 receptor, which plays a role in the brain’s control of body temperature.
The patient reported adverse symptoms within 40 days of starting Veozah. The person experienced fatigue, nausea, itching, suspected jaundice and more symptoms of liver injury. The patient’s liver blood test values were elevated, including abnormal liver enzymes and bilirubin levels. After stopping the medicine, the patient’s symptoms gradually went away, and blood test values slowly returned to normal.
Healthcare provider guidance
Healthcare professionals are urged to perform baseline liver function tests before prescribing Veozah and monitor patients closely throughout the treatment period. They should also educate patients about the signs of liver injury and the importance of regular testing.
