title: Long-term comparative pharmacovigilance of orally transmitted Chagas disease: first report.
abstract: Two old drugs are the only choice against Trypanosoma cruzi and little is known about their secondary effects in the acute stage of oral-transmitted Chagas disease (ChD).
  
  
  
  A cross-sectional analytical surveillance study was conducted in a sizable cohort of patients seen during the largest acute foodborne ChD microepidemic registered so far. Individuals were treated with benznidazole (BNZ) or nifurtimox (NFX). 'Common Terminology Criteria for Adverse Events' was assessed to categorize side effects according to severity.
  
  
  
  Out of 176 treatments applied, 79% had one or more adverse effects, which predominated in adults (97.8%) as compared to children (75.5%). Risk of side effects with NFX was significantly higher than BNZ. Four adults and a child treated with NFX had severe side effects (pulmonary infarction, facial paralysis, neutropenia, blurred vision, bone marrow hypoplasia) warranting hospitalization, and drug suspension. Adverse effects frequently reported with NFX were abdominal pain, hyporexia, weight loss, headache, nausea and lymphocytosis, whereas skin rash, neurosensory effects, hyporexia, fatigue, pyrosis, abdominal pain and eosinophilia were observed with BNZ.
  
  
  
  Frequency and severity of side effects during treatment of acute oral infection by T. cruzi demand direct supervision and close follow-up, even in those asymptomatic, to prevent life-threatening situations.
authors.affiliation: a Sección de Inmunología, Instituto de Medicina Tropical, Facultad de Medicina , Universidad Central de Venezuela (IMT-FM-UCV) , Caracas , Venezuela.
authors.forename: Belkisyolé
authors.initials: B
authors.lastname: Alarcón de Noya
authors.affiliation: b Cátedra de Parasitología , Escuela de Medicina 'Luís Razetti', FM-UCV , Caracas , Venezuela.
authors.forename: Raiza
authors.initials: R
authors.lastname: Ruiz-Guevara
authors.affiliation: c Sección de Biohelmintiasis , IMT-FM-UCV , Caracas , Venezuela.|d Centro para Estudios sobre Malaria , Instituto de Altos Estudios 'Dr. Arnoldo Gabaldón', Instituto Nacional de Higiene 'Rafael Rangel', Ministerio del Poder Popular para la Salud , Caracas , Venezuela.
authors.forename: Oscar
authors.initials: O
authors.lastname: Noya
authors.affiliation: e Sección de Infectología , IMT-FM-UCV , Caracas , Venezuela.
authors.forename: Julio
authors.initials: J
authors.lastname: Castro
authors.affiliation: e Sección de Infectología , IMT-FM-UCV , Caracas , Venezuela.
authors.forename: John
authors.initials: J
authors.lastname: Ossenkopp
authors.affiliation: a Sección de Inmunología, Instituto de Medicina Tropical, Facultad de Medicina , Universidad Central de Venezuela (IMT-FM-UCV) , Caracas , Venezuela.
authors.forename: Zoraida
authors.initials: Z
authors.lastname: Díaz-Bello
authors.affiliation: a Sección de Inmunología, Instituto de Medicina Tropical, Facultad de Medicina , Universidad Central de Venezuela (IMT-FM-UCV) , Caracas , Venezuela.|b Cátedra de Parasitología , Escuela de Medicina 'Luís Razetti', FM-UCV , Caracas , Venezuela.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Colmenares
authors.affiliation: e Sección de Infectología , IMT-FM-UCV , Caracas , Venezuela.
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Suárez
authors.affiliation: f Seccion de Ecología Parasitaria , IMT-FM-UCV , Caracas , Venezuela.
authors.forename: Oscar
authors.initials: O
authors.lastname: Noya-Alarcón
authors.affiliation: e Sección de Infectología , IMT-FM-UCV , Caracas , Venezuela.
authors.forename: Laura
authors.initials: L
authors.lastname: Naranjo
authors.affiliation: g Cátedra de Pediatría , Escuela 'Luis Razetti', FM-UCV , Caracas , Venezuela.
authors.forename: Humberto
authors.initials: H
authors.lastname: Gutiérrez
authors.affiliation: h Instituto Municipal de Cooperación y Atención de la Salud (IMCAS)  , Salud Chacao. Alcaldía del Municipio Chacao , Caracas , Venezuela.
authors.forename: Giuseppa
authors.initials: G
authors.lastname: Quinci
authors.affiliation: e Sección de Infectología , IMT-FM-UCV , Caracas , Venezuela.
authors.forename: Jaime
authors.initials: J
authors.lastname: Torres
mesh_terms: D014355:Chagas Disease / Q000188:drug therapy* / Q000453:epidemiology; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008297:Male; D009547:Nifurtimox / Q000009:adverse effects* / Q000627:therapeutic use; D009593:Nitroimidazoles / Q000009:adverse effects* / Q000627:therapeutic use; D060735:Pharmacovigilance; D014344:Trypanocidal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D014349:Trypanosoma cruzi / Q000187:drug effects
chemical_list: D009593:Nitroimidazoles; D014344:Trypanocidal Agents; D009547:Nifurtimox; C009999:benzonidazole
keywords: Chagas disease; benznidazole; nifurtimox; pharmacovigilance; side effects; treatment