RT info:eu-repo/semantics/article
T1 Baptista T, Motuca M, Serrano A, Perez Lo Presti A, Fernandez-Arana A, Olmos I, Pabon A, Yepez JGA, Alejo Galarza GJ, Rivera Ramirez NM, Elkis H, Sanz EJ, De Las Cuevas C, de Leon J. An expert review of clozapine in Latin American countries: Use, monitoring, and pharmacovigilance. Schizophr Res. 2024 Jun;268:60-65. doi: 10.1016/j.schres.2023.10.025. Epub 2023 Nov 18. PMID: 37985318.
T2 clozapine pharmacovigilance in Latin American
A1 Cuevas Castresana, Carlos de las
A1 Baptista, Trino
A1 Motuca, Mariano
A1 Serrano, Ana
A1 Perez Lo Presti, Alirio
A1 Fernandez-Arana, Alberto
A1 Olmos, Ismael
A1 Pabon, Albis
A1 Ayala Yépez, Juan Genaro
A1 Alejo Galarza, Gabriel de Jesús
A1 Rivera Ramirez, Nuria Monserrat
A1 Helkis, Helio
A1 Sanz, Emilio J.
A1 de León, José
A2 Medicina InternaDermatología y Psiquiatría
K1 Adverse effects
K1 antipsychotic agents
K1 clozapine
K1 hospitals
K1 pharmacovigilance
K1 risk assessment
AB There is a growing interest all around the world in clozapine clinical use, monitoring, and research, particularly adverse drug reactions (ADRs) other that 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 minimal advisable psychiatric beds (15 per 100.000 habitants):Uruguay (N= 34.9) and Argentine (N= 17). Bolivia is the only country where clozapine isunavailable. Nine out of twenty countries (45%) reported ADRs to VigiBase. 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 drugtitration in not described in package inserts in any country. We examined in detail the 9most 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 Argentine(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 on VigiBase has no relation with the country 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 people with severe mental and some neurological disorders.
YR 2023
FD 2023
LK http://riull.ull.es/xmlui/handle/915/39612
UL http://riull.ull.es/xmlui/handle/915/39612
LA en
DS Repositorio institucional de la Universidad de La Laguna
RD 27-abr-2025