Other safety alerts
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| European Union: Veoza (fezolinetant): new recommendations to minimise risk of liver injury |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) has agreed to a direct healthcare professional communication (DHPC) informing of the risk of drug-induced liver injury (DILI) with Veoza (fezolinetant) and has recommended monitoring of liver function before and during treatment.
Veoza is a medicine used to treat moderate-to-severe vasomotor symptoms (also referred to as hot flushes or night sweats) associated with menopause.
The committee considered a review of the potential risk of fezolinetant to cause drug-induced liver injury based on information from all available sources, including reports of suspected side effects and studies published in the scientific literature.
Severe elevations of the liver enzymes alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (>10x upper limit of normal) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP) have been reported post marketing in women taking Veoza. In some cases, elevated liver function tests (LFTs) were associated with signs or symptoms suggestive of liver injury such as fatigue, pruritus, jaundice, dark urine, decreased appetite, or abdominal pain.
PRAC recommends LFTs must be performed before treatment is started. During the first three months of treatment, monthly LFTs must be carried out, and thereafter based on clinical judgement. During treatment, LFTs must be conducted if symptoms suggestive of liver injury occur. Monitoring of liver function should be maintained until they have normalised.
Treatment should be discontinued in certain cases of transaminase and bilirubin elevations or if liver enzyme elevations are accompanied by symptoms suggestive of liver injury.
The summary of product characteristics and package leaflet of Veoza are being updated to reflect the new risk information and recommendations.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-november-2024
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 13 Sep 2024.
Ends/Saturday, Nov 30, 2024
Issued at HKT 12:00
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