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Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database.
Kim, Seonji; Park, Kyounghoon; Kim, Mi-Sook; Yang, Bo Ram; Choi, Hyun Jin; Park, Byung-Joo.
Afiliación
  • Kim S; Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • Park K; Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • Kim MS; Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • Yang BR; Medical Research Collaborating Center, Seoul National University Hospital and Seoul National University College of Medicine, Seoul, Korea.
  • Choi HJ; Research Coordination Center for Rare Diseases, Seoul National University Hospital, Korea.
  • Park BJ; Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea. Electronic address: bjpark@snu.ac.kr.
Psychiatry Res ; 256: 237-242, 2017 10.
Article en En | MEDLINE | ID: mdl-28646789
Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database. We defined signals in this study by the reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) indices. The KAERS database included 860,224 AE reports, among which 866 reports contained fluoxetine. We compared the labels of fluoxetine among the United States, UK, Germany, France, China, and Korea. Some of the signals, including emotional lability, myositis, spinal stenosis, paradoxical drug reaction, drug dependence, extrapyramidal disorder, adrenal insufficiency, and intracranial hemorrhage, were not labeled in the six countries. In conclusion, we identified new signals that were not known at the time of market approval. However, certain factors should be required for signal evaluation, such as clinical significance, preventability, and causality of the detected signals.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fluoxetina / Sistemas de Registro de Reacción Adversa a Medicamentos / Inhibidores Selectivos de la Recaptación de Serotonina / Etiquetado de Medicamentos / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos Tipo de estudio: Etiology_studies / Prognostic_studies Límite: Humans País/Región como asunto: America do norte / Asia / Europa Idioma: En Revista: Psychiatry Res Año: 2017 Tipo del documento: Article Pais de publicación: Irlanda
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fluoxetina / Sistemas de Registro de Reacción Adversa a Medicamentos / Inhibidores Selectivos de la Recaptación de Serotonina / Etiquetado de Medicamentos / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos Tipo de estudio: Etiology_studies / Prognostic_studies Límite: Humans País/Región como asunto: America do norte / Asia / Europa Idioma: En Revista: Psychiatry Res Año: 2017 Tipo del documento: Article Pais de publicación: Irlanda