The FDA added a warning about rare serious liver injury to Veozah on 12 September 2024.
A Springer paper published on 4 August used the FDA’s FAERS system to look for adverse-event signals with fezolinetant, the first approved non-hormonal neurokinin-3 receptor antagonist for moderate to severe vasomotor symptoms of menopause.
The analysis was a disproportionality study, which can spot reports that appear more often than expected in routine use but cannot prove fezolinetant caused them. FAERS is a spontaneous reporting database, not a controlled trial cohort, and its entries can be incomplete, duplicated or skewed by media attention and reporting bias.
Astellas sent a Dear Healthcare Professional letter in January 2025 saying serious liver injury had been observed and liver-monitoring advice was being updated. The FDA prescribing information now carries a boxed warning for hepatotoxicity and says hepatic laboratory tests should be done before treatment starts. In the UK, the MHRA and Astellas issued a January 2025 warning on drug-induced liver injury and new monitoring recommendations, and the British Menopause Society highlighted that guidance again in April 2025.
The MHRA licensed fezolinetant on 14 December 2023, and the British Menopause Society said it was expected on private prescription from mid-January 2024. NICE final draft guidance in March 2026 said it can be used for moderate to severe vasomotor symptoms caused by menopause when hormone replacement therapy is unsuitable, and on 11 March 2026 the British Menopause Society said NICE supported NHS prescribing.
The questions for a GP appointment are whether HRT is unsuitable in a specific case, whether baseline liver tests are needed, how often liver function should be checked, and whether any other medicines could complicate treatment.