Warning over menopause drug and ‘rare but serious’ liver injury risk

Dr Karen Magraith says the single case of liver injury appeared to resolve after the patient stopped taking the drug.
Dr Karen Magraith.

The US medicines watchdog has recommended more frequent liver testing for patients taking the new non-hormonal menopause drug fezolinetant after an isolated but serious liver injury case.

Last month, the Food and Drug Administration (FDA) updated prescribing information for fezolinetant (Veoza) after one patient developed liver injury symptoms within 40 days of initiation.

The patient reported fatigue, nausea, itching, yellow eyes and skin, light-coloured stools and dark urine, all of which resolved gradually after stopping treatment, the FDA said.

“Healthcare professionals should conduct hepatic laboratory testing before prescribing Veoza, then every month for the first three months after patients start treatment, and then at months six and nine of treatment,” it advised.