title: Profile of idiosyncratic drug induced liver injury in Latin America: an analysis of published reports.
abstract: BACKGROUND
  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.
  
  
  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.
authors.affiliation: Hospital de Clínicas, Clínica de Gastroenterología, Facultad de Medicina, Universidad de la República, Montevideo, Uruguay.
authors.forename: Nelia
authors.initials: N
authors.lastname: Hernández
authors.affiliation: Facultad de Ciencias Médicas, Servicio de Gastroenterología y Hepatología, Hospital Provincial del Centenario. Universidad Nacional de Rosario, Argentina.
authors.forename: Fernando
authors.initials: F
authors.lastname: Bessone
authors.affiliation: Hospital de Clínicas, Clínica de Gastroenterología, Facultad de Medicina, Universidad de la República, Montevideo, Uruguay.
authors.forename: Adriana
authors.initials: A
authors.lastname: Sánchez
authors.affiliation: Hospital de Clínicas, Clínica de Gastroenterología, Facultad de Medicina, Universidad de la República, Montevideo, Uruguay.
authors.forename: María
authors.initials: M
authors.lastname: di Pace
authors.affiliation: Sección de Gastroenterología, Departamento de Medicina Interna, Hospital Clínico Universidad de Chile y Departamento de Gastroenterología, Clínica Las Condes, Santiago, Chile.
authors.forename: Javier
authors.initials: J
authors.lastname: Brahm
authors.affiliation: Departamento de Gastroenterología, Hospital Salvador. Universidad de Chile y Clínica Alemana de Santiago. Universidad del Desarrollo, Santiago, Chile.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Zapata
authors.affiliation: Hospital Ángeles de Pedregal, México, D.F.
authors.forename: Ruby
authors.initials: R
authors.lastname: A Chirino
authors.affiliation: Servicio de Hígado. Departamento del Aparato Digestivo. Hospital Nacional Edgardo Rebagliati. Lima, Perú
authors.forename: Milagros
authors.initials: M
authors.lastname: Dávalos
authors.affiliation: Departamento de Investigación Biomédica. Unidad de Hepatología, Fundación Clínica Médica Sur. Ciudad de México, México.
authors.forename: Nahum
authors.initials: N
authors.lastname: Méndez-Sánchez
authors.affiliation: Departamento de Gastroenterología, Facultad de Medicina Pontificia. Universidad Católica de Chile, Santiago. Chile.
authors.forename: Marco
authors.initials: M
authors.lastname: Arrese
authors.affiliation: Hospital Universitario Edgar Santos. Universidad Federal de Bahía. Salvador de Bahía. Brazil.
authors.forename: María
authors.initials: M
authors.lastname: Schinoni
authors.affiliation: 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.
authors.forename: M Isabel
authors.initials: MI
authors.lastname: Lucena
authors.affiliation: 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.
authors.forename: Raúl J
authors.initials: RJ
authors.lastname: Andrade
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D017373:Cyproterone Acetate / Q000009:adverse effects; D005260:Female; D005485:Flutamide / Q000009:adverse effects; D006801:Humans; D007843:Latin America / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D013449:Sulfonamides / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D013449:Sulfonamides; D017373:Cyproterone Acetate; D005485:Flutamide; C012655:nimesulide