QUelques weeks after its marketing in France, the specialty Veoza 45 mg film -coated tablet (fezolinent) is the subject of a safety alert relating to the risk of liver damage [1, 2].
The ASTELLAS PHARMA laboratory and the National Medicines Safety Agency and Health Products (ANSM) emphasize the precautions for use to be respected and biological and clinical control and monitoring measures to be implemented in all patients, before and during treatment with Veoza.
As a reminder, Veoza is indicated in the treatment of moderate to severe vasomotor symptoms (SVM) associated with menopause (cf. Our article of April 10, 2025). This medication is subject to compulsory medical prescription.
Known hepatic risk of indeterminate frequency
The risk of liver damage associated with Veoza is mentioned in the summary of product characteristics (RCP) and in the instructions. The frequency of this undesirable effect is indefinite.
Increasing serum rates of Alanine Aminotransferase (ALAT) or Aspartate Aminotransferase (ASAT) have been observed in clinical trials. After the marketing of Veoza in the European Union, serious cases with increases in transaminases (> 10 x limit higher than normal [LSN]) and with concomitant increase in bilirubin and/or alkaline phosphatase (PAL) were reported in pharmacovigilance data.
In some cases, the elevation of the hepatic assessment parameters has been associated with signs and symptoms evoking a liver lesion such as fatigue, pruritus, jaundice, dark urine, clear, nausea, vomiting, diminishment, diminished and/or abdominal pain.
The biological and clinical side effects were generally reversible when you stop treatment.
Biological and clinical monitoring
Before establishing the treatment
Due to this liver risk, a liver balance must be carried out before establishing the treatment with Veoza.
-Veoza should not be initiated In patients whose liver balance is abnormal, that is to say in case:
- serum rate of Alanine Aminotransferase (ALAT) or aspartate aminotransferase (ASAT) greater than or equal to 2 times the limit higher than normal (≥ 2x LSN);
- or total bilirubin level ≥ 2x lsn.
During treatment
Once the treatment is started, the liver function should be monitored (biological control and clinical surveillance):
- every month for the first 3 months;
- Then depending on the clinical context: the liver balance should be carried out in the presence of symptoms suggesting a liver damage.
Treatment must be arrested :
- If elevation of transaminases ≥ 3x lsn with total bilirubin> 2x lsn OR liver damage symptoms;
- or if elevation of transaminases> 5x lsn.
Training of liver function should be continued until standardization.
Inform patients about the driving to hold
Patients should be informed about the liver risk associated with Veoza, and the signs and symptoms of liver damage to alert them:
- fatigue ;
- pruritus (itching);
- jaundice (jaundice);
- dark urine;
- clear stools;
- nausea, vomiting;
- decrease in appetite;
- and/or abdominal pain.
The occurrence of these symptoms must lead them to consult immediately A doctor.
