| アブストラクト | Pharmacovigilance findings have marked clozapine use. Prescribers and package inserts worldwide focus on clozapine-induced neutropenia. The literature on clozapine adverse drug reactions (ADRs) for those under age 18 and their associated fatal outcomes is limited. Reports to the World Health Organization's global pharmacovigilance database (VigiBase) were analyzed among patients under 18 years of age extending from clozapine's introduction to June 1, 2022. There were 2825 reports of clozapine, including 42 fatal outcomes (relative lethality = 1.5% vs. 11.7% in all ages). After 280 cases were excluded (clozapine exposure during pregnancy, accidental exposure or unclear age), 2455 were included with ADRs during therapeutic use. Decreased white blood cell (WBC) count provided the most frequent aggregated ADR, accounting for 934 cases (37% of 2545), with only 1 fatal outcome (0.01%, 1/934). Suicide explained 7 of 27 (26%) non-duplicated fatal outcomes. Next in importance was clozapine-induced gastrointestinal hypomotility (CIGH) with 3 cases (11% of 27) and neuroleptic malignant syndrome with 2 cases (7% of 27). Agranulocytosis, aspiration, myocarditis, myocardiopathy and ventricular arrythmia led to single fatal cases. Based on these new findings and recent literature in all ages, to prevent fatal outcomes, child and adolescent psychiatrists need to shift their focus from severe neutropenia to other ADRs including pneumonia, respiratory aspiration and CIGH. In spite of its potential toxicity during overdoses, clozapine may have specific and strong anti-suicidal effects when compared with other antipsychotics. Child and adolescent psychiatrists need to take extreme precautions to avoid intentional overdoses when prescribing clozapine to patients with suicide risk. |
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| 組織名 | Department of Internal Medicine, Dermatology and Psychiatry, Instituto;Universitario de Neurociencia (IUNE), Universidad de La Laguna, La Laguna, Canary;Islands, Spain. ccuevas@ull.edu.es.;Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine,;University of La Laguna, Campus de Ofra s/. 38071, San Cristobal de La Laguna,;Canary Islands, Spain. ccuevas@ull.edu.es.;Department of Physical Medicine and Pharmacology, School of Medicine, Universidad;de La Laguna, La Laguna, Canary Islands, Spain.;Hospital Universitario de Canarias, Tenerife, Spain.;Child and Adolescent Mental Health Unit, University Hospital Virgen de las;Nieves, Granada, Spain.;CTS-549 Research Group (Psychiatry and Neurosciences), Granada, Junta de;Andalucia, Spain.;Institute of Neurosciences, Biomedical Research Centre, University of Granada,;Granada, Spain.;Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital,;University of Zurich, Zurich, Switzerland.;Psychiatry Research, The Zucker Hillside Hospital, Northwell Health, Glen Oaks,;NY, USA.;Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, 11549, USA.;The National Clinical Research Centre for Mental Disorders & Beijing Key Lab of;Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing,;China.;Advanced Innovation Center for Human Brain Protection, Capital Medical;University, Beijing, China.;Mental Health Research Center, Eastern State Hospital, Lexington, KY, USA.;Biomedical Research Centre in Mental Health Net (CIBERSAM), Santiago Apostol;Hospital, University of the Basque Country, Vitoria, Spain. |
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