Integrating pharmacovigilance, pharmacokinetics and clinical outcomes in clozapine safety science.

Abstract

Clozapine remains the most effective treatment for treatment-resistant schizophrenia, yet its use is constrained by concerns about safety and preventable adverse outcomes. Evidence on clozapine safety remains fragmented and methodologically heterogeneous, limiting translation into clinical practice. Pharmacovigilance, therapeutic drug monitoring, pharmacokinetics and pharmacogenetics provide complementary information that is rarely considered together. This editorial argues that integrating these approaches within a coherent clinical framework may improve prediction and individualisation of risk while acknowledging current methodological limitations. Progress may therefore depend less on generating additional isolated evidence than on connecting the data already available.