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Fezolinetant risk of liver injury: Minimizing Liver Risk with New Guidelines

April 30, 2025

Close monitoring of drugs side effects is a necessity, since leaving it un attended can lead to serious complications that on the long run maybe hear to reverse.

Similarly, a recent European safety review that was performed on patients administering Fezolinetant for managing vasomotor symptoms associated with menopause, has showed concerning elevated levels of liver enzymes, bilirubin & transaminases accompanied with liver injury such as pale stool, itching of palms and soles, abdominal pain and dark urine.

Therefore, after multiple cases experiencing elevated levels of liver enzymes, bilirubin & transaminases after Fezolinetant administration for the treatment of moderate to severe vasomotor symptoms associated with menopause. Regular screening & monitoring is recommended

In the UK, between December 2023 and January 2025, the Yellow Card scheme received one spontaneous report of abnormal liver test results linked to Fezolinetant, with no reports of liver disorders. Currently, Fezolinetant is only available via private prescription.

Based on the recent  European review, new updates have taken place in order to minimize risk of liver injury which include:

  • Liver toxicity warnings for Fezolinetant have been strengthened.
  • Liver function tests are advised before treatment, monthly for 3 months, then as needed.
  • Avoid use in patients with liver disease or high liver risk.

Guidance for Managing Liver Enzyme Abnormalities:

  • Elevated liver enzymes and symptoms of liver injury typically resolved after stopping treatment.
  • Do not initiate treatment if ALT or AST levels are ≥2 times the upper limit of normal (ULN), or if total bilirubin is similarly elevated (≥2x ULN).
  • Discontinue treatment if liver injury is suspected or if liver function tests become abnormal, and continue monitoring until liver enzymes return to normal.

Healthcare professionals, patients, and caregivers are encouraged to report suspected adverse reactions to the Yellow Card scheme through its website, app, or supported clinical systems, including detailed medical and treatment information where possible

Learn more: Fezolinetant▼(Veoza): risk of liver injury; new recommendations to minimise risk - GOV.UK

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