Hepatic risk linked to a new medication against hot flashes
Since April 8, 2025, Veoza has been available in pharmacies to relieve heat puffs linked to menopause. But this fezolinentant medication is today the subject of a sanitary alert. L’National Medicines Safety Agency (ANSM) signals a Risk of serious liver damage associated with its use. In question: Case of liver toxicity Observed in clinical and confirmed trials after placing it on the market.
In a letter addressed to health professionals dated May 2, the ANSM recalls that “serious liver lesions have been observed with fezolinentant“”. The product, marketed by the Astellas Pharmaid laboratory, is now supervised by Strict liver monitoring recommendationsto respect before and during any prescription.
An ANSM alert from the marketing of the Veoza
From its marketing in France, Veoza was placed under vigilance. The European Medicines Agency (EMA) and the ANSM have identified cases of disturbing increase in transaminasesthe enzymes witness to the proper functioning of the liver.
According to the newsletter, some patients presented “Increases of ALAT and/or ASAT (> 10 x LSN) with concomitant increases in bilirubin and/or alkaline phosphatase “. Clear indicators of a severe liver damageup to a drug liver injury.
“”The risk of serious liver injury could significantly affect its benefit-risk ratio “specifies the ANSM. This is why a very supervised safety protocol is set up without delay, with a clear objective: to avoid any silent aggravation in treated patients.
What are the symptoms to know and monitor?
The danger of fezolinent is based on its ability to cause liver damage without immediate sign. It is therefore crucial toinform patients Alert signals.
The health authorities insist: “Inform the patient of signs and symptoms of liver lesion as fatigue, pruritus, jaundice, dark urine, clear stools, nausea, vomiting, decrease in appetite and/or abdominal pain “.
These demonstrations may appear several weeks after the start of treatment. In some cases, the lesions detected have been “generally reversible to stopping treatment “but require rapid detection to avoid sustainable damage.
Clear, Dialogue between doctor and patient becomes fundamental From the prescription.
A hepatic assessment before and during treatment becomes compulsory
Faced with the risk identified, the medical strategy is clear. No treatment should be started without a Prerequisite. If the results show that transaminases (alat or asat) or bilirubin are greater than 2x normalthe prescription is strictly contraindicated.
During first three monthsa monthly surveillance liver function is required. Then it will have to adapt according to the clinical situation.
Treatment must imperatively be interrupted ::
- In case ofElevation of transaminases ≥3x normal with liver symptoms or high bilirubin
- Or if transaminases exceed normal 5x 5xeven without symptoms
The ANSM specifies that “monitoring of liver function should be continued until standardization “. These precautions aim to Reduce risks while maintaining the therapeutic benefits of the drug.