Profile of idiosyncratic drug induced liver injury in Latin America: an analysis of published reports.

Authors:
Nelia Hernandez
Nelia Hernandez
Hospital de Clínicas
Fernando Bessone
Fernando Bessone
Hospital Provincial del Centenario
Argentina
Adriana Sanchez
Adriana Sanchez
Hospital de Clínicas
Caracas | Venezuela
Javier Brahm
Javier Brahm
Hospital Clínico Universidad de Chile
Chile
Dr. Rodrigo Zapata, MD, FAASLD
Dr. Rodrigo Zapata, MD, FAASLD
University of Chile School of Medicine
Associate Professor of Medicine
Santiago | Chile

Ann Hepatol 2014 Mar-Apr;13(2):231-9

Unidad de Hepatología y Servicio de Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga-IBIMA, Málaga. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), España.

Introduction: Drug-induced liver injury (DILI) remains a major problem for drug development and represents a challenging diagnosis for clinicians. The absence of specific biomarkers for diagnosing DILI precludes the availability of reliable data on the epidemiology of the disease. In this study we aimed to describe the features of idiosyncratic hepatotoxicity reports in Latin American countries.

Material And Methods: A literature search was performed using the online version of MEDLINE, EMBASE, Scopus, Google Scholar and specific data bases from Latin America (LA) (Scielo, Lilacs) to identify any case report or case series of published DILI from 1996 to 2012. From 1996 to 2012, a total of 176 patients with DILI were published in LA, involving 53 suspicious drugs. The median age in the adult population of these patients was 55 years (17-82) with prevalence of women (67%). Among main therapeutic classes, the rank order was led by non-steroidal anti-inflammatory (61 cases) and systemic antibacterial drugs (37 cases). Nimesulide was the individual drug responsible for the highest number of cases (53), followed by cyproterone acetate (18), nitrofurantoin (17), antituberculous drugs (13) and flutamide (12). Thirty two percent of published cases evolved to acute liver failure (ALF), and half of the subjects required liver transplantation or eventually died.

Conclusions: This study represents the first structured attempt to assess the spectrum of DILI profile in LA. The establishment of a Latin American registry to collect prospective DILI cases using a standardized protocol will advance our knowledge about idiosyncratic DILI in this region.

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November 2014
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