| アブストラクト | There is growing interest in clozapine clinical use, monitoring, and research, particularly adverse drug reactions (ADRs) other than agranulocytosis. In this study we focused on clozapine pharmacovigilance. Hence, we contacted clinicians and researchers in Latin America and requested information about local psychiatric services, clozapine availability, clinical use, and ADR monitoring with the VigiBase system. Only two countries have the minimum recommended number of psychiatric beds (15 per 100,000 residents): Uruguay (N = 34.9) and Argentina (N = 17). Bolivia is the only country where clozapine is unavailable. Nine out of twenty countries (45 %) reported ADRs to VigiBase. Argentina, Brazil, Chile, Colombia, and Mexico published national guidelines for schizophrenia treatment. Chile is the sole country with clozapine clinics with drug serum monitoring. Ethnicity-related drug titration in not described in package inserts in any country. We examined in detail the 9 most frequent and important clozapine ADRs in the worldwide database (pneumonia, sudden death, cardiac arrest, agranulocytosis, myocarditis, constipation, arrhythmia, seizure, and syncope). These 9 ADRs led to 294 reports with fatal outcomes in Argentina (N = 3), Brazil (N = 3), Chile (N = 2), and Peru (N = 1). Agranulocytosis was reported from 7 countries: constipation or seizures from 8 countries. Only two countries reported pneumonia and one country reported myocarditis. The number of clozapine reports in VigiBase has no relationship to the country's population. All Latin American countries underreport clozapine associated ADRs. Latin American governments, along with clinicians, researchers, and educators, should optimize clozapine use and monitoring for the benefit of people with severe mental and some neurological disorders. |
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| 投稿者 | Baptista, Trino; Motuca, Mariano; Serrano, Ana; Perez Lo Presti, Alirio; Fernandez-Arana, Alberto; Olmos, Ismael; Pabon, Albis; Yepez, Juan Genaro Ayala; Alejo Galarza, Gabriel de Jesus; Rivera Ramirez, Nuria Monserrat; Elkis, Helio; Sanz, Emilio J; De Las Cuevas, Carlos; de Leon, Jose |
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| 組織名 | Department of Physiology, Los Andes University Medical School, Merida, Venezuela;;Medical School, Anahuac University, Queretaro, Mexico; Neuroorigen, Queretaro,;Mexico. Electronic address: trinobaptista@gmail.com.;Department of Psychiatry, School of Medicine at Universidad Nacional de Cuyo,;Mendoza, Argentina; Instituto Vilaprino, Centro de Estudios, Asistencia e;Investigacion en Neurociencias, Mendoza, Argentina.;SAMEIN, Salud Mental Integral SAS, Medellin, Colombia.;Centro de Salud Mental y Comunitario Dr German Greve Schlegel, Santiago, Chile.;Instituto de Neurociencias Aplicadas, Lima, Peru.;Clinical Pharmacology Unit and Pharmacy Department, Vilardebo Hospital,;Administracion de Servicios de Salud, Montevideo, Uruguay; Clinical Pharmacology;Unit and Outpatient Clinic, Vilardebo Hospital, Administracion de Servicios de;Salud, Montevideo, Uruguay.;Los Andes University Hospital, Psychiatric Unit, Merida, Venezuela.;Posgrado de Psiquiatria, Facultad de Ciencias Medicas de la Universidad Central;del Ecuador, Quito, Ecuador; Centro Ambulatorio especializado San Lazaro,;Ministerio de Salud Publica, Quito, Ecuador.;Instituto Regional de Psiquiatria e Investigacion, San Luis Potosi, Mexico.;Department and Institute of Psychiatry, University of Sao Paulo Medical School,;Sao Paulo, Brazil.;Department of Physical Medicine and Pharmacology, School of Medicine, Universidad;de La Laguna, Canary Islands, Spain; Hospital Universitario de Canarias,;Tenerife, Spain.;Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine,;University of La Laguna, Canary Islands, Spain; Instituto Universitario de;Neurociencia (IUNE), Universidad de La Laguna, San Cristobal de La Laguna, Spain.;Mental Health Research Center at 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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