Drug Safety Update - April 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Drug Safety Update for April 2025.
This update warns clinicians about the risk of liver injury with fezolinetant▼ (Veoza®). This is a relatively new treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause. Cases of serious liver injury with deranged liver function tests and signs and symptoms of hepatic dysfunction have been reported. These findings were generally reversible on discontinuation of therapy.
Clinicians are advised to avoid fezolinetant in patients with known liver disease or patients at higher risk for liver disease. Baseline liver checks are also advised with tests repeated monthly for the first three months of treatment and periodically thereafter.
Treatment must be discontinued in patients who develop symptoms of liver injury or when transaminases are above three times the upper limit of normal (3xULN) or bilirubin is above 2xULN. Liver monitoring is recommended should any signs or symptoms suggestive of liver injury occur and patients should be advised to seek immediate medical attention if they develop such signs. This would include fatigue, pruritus, jaundice, dark urine, pale faeces, nausea, vomiting, decreased appetite and/or abdominal pain. Any suspected adverse drug reactions associated with fezolinetant should be reported via the Yellow Card scheme.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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