
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee has recommended easing routine blood count monitoring for patients on clozapine, citing new data that show that the risk for severe neutropenia and agranulocytosis declines significantly after the first year of treatment. Under the updated guidelines, monitoring for patients without a history of neutropenia can be reduced to once every 12 weeks after the first year, and to once annually after 2 years. In addition, absolute neutrophil count (ANC) will now be the sole parameter used for hematologic monitoring, replacing the previous requirement to also measure white blood cell count. The revised recommendations are supported by a joint expert statement from the European Clozapine Task Force, published this year, which called for changes to the monitoring protocol due to the very low incidence of late-onset agranulocytosis.