Clozapine: The commitment to patient safety

Clozapine represents the "gold standard" therapy for treatment-resistant sc hizophrenia including use for symptom reduction and use in patients intoler ant of extrapyramidal side effects associated with other antipsychotics. De spite its clear benefit in these areas, its use has been associated with a serious, and sometimes life-threatening, risk for agranulocytosis. Effectiv e white blood cell monitoring systems have been developed by Novartis affil iates across the world to ensure its safe use and to meet local health stan dards. The goals of the monitoring programs include: (1) weekly white blood cell monitoring during the initial months of therapy for early detection o f severe leukopenia; (2) immediate discontinuation of clozapine if severe l eukopenia is observed; (3) exclusion from reexposure to clozapine if a pati ent experiences clozapine-induced agranulocytosis; and (4) early cessation of treatment if hematologic guidelines are not followed ("no blood, no drug " policy). Together, these systems have demonstrated a worldwide reduction in the observed rate of agranulocytosis and in fatalities related to the em ergence of agranulocytosis when rigorous monitoring systems are in place.