Abstract In 2025, the European Medicines Agency (EMA) following a Pharmacovigilance Risk Assessment Committee (PRAC) review, revised routine haematological monitoring recommendations for clozapine. We examine the evidence supporting changes to clozapine haematological monitoring requirements and describe the revised clozapine haematological monitoring recommendations. We include a patient perspective, highlighting a patient’s view of the recommended changes including possible advantages, concerns, and the potential for less burdensome care. This perspective article summarises the regulatory changes, the evidence supporting them, and clinical implications. Key changes include switching to absolute neutrophil count (ANC)-only monitoring, updated ANC thresholds for initiation/continuation (with specific allowances for benign ethnic neutropenia (BEN)), and substantial reductions in monitoring frequency after the first year(s) in patients without neutropenia.
Lally et al. (Wed,) studied this question.