title: FDA changes clozapine monitoring guidelines: Implications for worldwide practice.
abstract: US FDA decision to change their clozapine monitoring guidelines in 2015 for the first time. The changes proposed are as follows: lowering the neutrophil count before ceasing clozapine from 1.5 to 1.0×10(9)/l, allowing the potential for re-challenge following severe neutropenia (<1.0×10(9)/l) and allowing those with benign ethnic neutropenia the opportunity to be commenced on clozapine. These changes will allow a greater number of patients with schizophrenia in USA to be continued on clozapine. In our correspondence we summarize the evidence that support these changes. The FDA changes will likely have impact on clozapine monitoring protocols in other countries.
authors.affiliation: South Australian Health and Medical Research Institute (SAHMRI) - Mind and Brain, Adelaide, Australia.
authors.forename: Tarun
authors.initials: T
authors.lastname: Bastiampillai
authors.affiliation: Department of Psychiatry, Flinders Medical Centre, Adelaide, Australia. Electronic address: arun.gupta@sa.gov.au.
authors.forename: Arun
authors.initials: A
authors.lastname: Gupta
authors.affiliation: Department of Psychiatry, Flinders Medical Centre, Adelaide, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Allison
mesh_terms: D000380:Agranulocytosis / Q000139:chemically induced*; D003024:Clozapine / Q000009:adverse effects*; D016903:Drug Monitoring / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D009503:Neutropenia / Q000139:chemically induced; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D003024:Clozapine
keywords: Agranulocytosis; Benign ethnic neutropenia; Clozapine monitoring protocol; US FDA