Clozapine-associated neutropenia and agranulocytosis in Argentina (2007-2012)
| Autor: | Viviana G. Bologna, Ross J. Baldessarini, Rosa M. Papale, Osvaldo U. Garay, Juan I. Balasini, Cintia R. Prokopez, Federico Manuel Daray, Inés Bignone, Andrés Brandolini, María Victoria Balda |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Pediatrics medicine.medical_specialty CIENCIAS MÉDICAS Y DE LA SALUD Neutropenia MEDLINE Argentina Medicina Clínica Pharmacovigilance Age Distribution Risk Factors medicine Humans Pharmacology (medical) Registries Clozapine Psiquiatría Leukopenia business.industry Middle Aged medicine.disease Psychiatry and Mental health Age distribution Female medicine.symptom business medicine.drug Agranulocytosis Antipsychotic Agents |
| Zdroj: | International clinical psychopharmacology. 30(2) |
| ISSN: | 1473-5857 |
| Popis: | The risks of severe leukopenia and agranulocytosis have varied over time and among geographical regions and cultures, with little information available on South American populations. Accordingly, we reviewed and analyzed data from a 6-year experience monitored by an Argentine national registry to which reporting of adverse events reports is required. We analyzed data for 2007-2012 from the pharmacovigilance program of the Argentine drug-regulatory agency (ANMAT) using standard bivariate and multivariate statistical methods and survival analysis. We identified 378 cases of adverse hematological events over 6 years among an average of 12 305 individuals/year treated with clozapine (308±133 mg/day) to estimate the mean annualized rates of leukopenia [0.19 (95% confidence interval [CI] 0.11-0.27)], neutropenia [0.38 (95% CI 0.34-0.43)], and agranulocytosis [0.05 (95% CI 0.02-0.08)] % per year [median latency 2 (95% CI 1.3-2.1) months]; fatalities related to agranulocytosis averaged 4.2 (95% CI 0.0-9.2) per 100 000 treated individuals/year. Factors associated significantly and independently with agranulocytosis were female sex, older age, and use of other drugs in addition to clozapine. With monitoring by international standards, recent risks of clozapine-associated agranulocytosis in Argentina were lower, but fatality rates were higher than that in other regions of the world. Risk factors include the use of multiple psychotropic drugs, female sex, and older age. Fil: Balda, María Victoria. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina Fil: Garay, Osvaldo U.. Instituto de Efectividad Clinica y Sanitaria; Argentina Fil: Papale, Rosa M.. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina Fil: Bignone, Inés. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina Fil: Bologna, Viviana G.. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina Fil: Brandolini, Andrés. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina Fil: Prokopez, Cintia R.. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina Fil: Balasini, Juan I.. Ministerio de Economía y Finanzas Públicas. Secretaría de Política Económica; Argentina Fil: Baldessarini, Ross J.. Harvard Medical School; Estados Unidos Fil: Daray, Federico Manuel. Universidad de Buenos Aires. Facultad de Medicina. Cátedra de Farmacología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina |
| Databáze: | OpenAIRE |
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