HPRA Drug Safety Newsletter 121
22/12/2025
Medicines for human use
Safety update
The latest edition of the HPRA newsletter includes important updates to support the safe and appropriate use of the following medicines:
- Fezolinetant: Risk of drug-induced liver injury and new recommendations on monitoring of liver function before and during treatment.
- Enzalutamide and digoxin: Laboratory test interference leading to falsely elevated digoxin plasma levels and a reminder of the existing interaction.
- Glucagon-like peptide-1 (GLP-1) analogues: Highlight and reminder of certain safety aspects.
- Product information updates recommended by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).
- Direct Healthcare Professional Communications published on the HPRA website since the last Drug Safety Newsletter.