FDA Issues Warning on Rare Liver Injury Risk with Veozah (Fezolinetant) for Menopausal Hot Flashes

FDA Warning:
The FDA has added a warning about the rare but serious risk of liver injury associated with Veozah (fezolinetant), a nonhormonal prescription medicine used to treat moderate to severe hot flashes due to menopause.

Postmarketing Case:
The warning was prompted by a postmarketing review of a patient who developed elevated liver blood test values and signs of liver injury after taking Veozah for approximately 40 days.

Updated Recommendations:

Liver Function Testing:
Healthcare professionals should conduct liver function tests before starting Veozah and then monthly for the first three months, followed by tests at months 6 and 9 of treatment.

Patient Monitoring:
Patients should be informed about the risk of liver injury and instructed to stop Veozah immediately and contact their healthcare professional if they experience signs of liver problems, such as fatigue, jaundice, nausea, vomiting, unusual itching, light-colored stools, or dark urine.

Background:
Veozah (fezolinetant) was approved by the FDA in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. It works by blocking the activities of the NK3 receptor, which plays a role in the brain’s control of body temperature.

Impact:
Despite the additional warning, analysts suggest that the updated label may not significantly impact demand for Veozah, as the additional testing requirements, while burdensome, are seen as strengthening the drug’s safety profile.