title: Adverse events after the use of benznidazole in infants and children with Chagas disease.
abstract: BACKGROUND
  Chagas disease is caused by infection with Trypanosoma cruzi. In adults, treatment with benznidazole is associated with a high incidence of adverse drug reactions (ADRs). However, in infants and children, treatment with benznidazole seems associated with a lower incidence and decreased severity of ADRs, but these effects have not been clearly characterized.
  
  
  OBJECTIVE
  We aimed to describe ADRs observed in infants and children treated with benznidazole.
  
  
  METHODS
  We conducted a prospective cohort study of infants and children in Argentina with Chagas disease treated with benznidazole.
  
  
  RESULTS
  A total of 107 infants and children diagnosed with asymptomatic Chagas disease (mean age: 6.9 years) were enrolled in the study. Sixty-two events (in 44 children) were considered benznidazole related. Mean ADR duration was 8.2 days. ADRs were mild (80.6%), moderate (16%), or severe (3.2%). Most (77.3%) ADRs were in children older than 7 years. Skin was the organ with the highest incidence of ADRs (21%), followed by the central nervous system (9%) and the gastrointestinal tract (8.5%). Also, the ADR rate was lower in infants and toddlers compared with older children (18% vs 53%) (P < .001).
  
  
  CONCLUSIONS
  Treatment with benznidazole was well tolerated in children. Most ADRs were mild and did not require treatment suspension. A strong association was observed between ADR incidence and patient age, and most ADRs occurred in children older than 7 years. We believe that anxiety over potential severe ADRs in children with Chagas disease is not justified and should not be an obstacle to using benznidazole.
authors.affiliation: Servicio de Parasitología y Enfermedad de Chagas, Hospital de Niños R. Gutierrez, Gallo 1330, Buenos Aires 1425, Argentina. jaltcheh@gmail.com
authors.forename: Jaime
authors.initials: J
authors.lastname: Altcheh
authors.forename: Guillermo
authors.initials: G
authors.lastname: Moscatelli
authors.forename: Samanta
authors.initials: S
authors.lastname: Moroni
authors.forename: Facundo
authors.initials: F
authors.lastname: Garcia-Bournissen
authors.forename: Hector
authors.initials: H
authors.lastname: Freilij
mesh_terms: D000293:Adolescent; D014355:Chagas Disease / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009593:Nitroimidazoles / Q000009:adverse effects*; D011446:Prospective Studies; D014344:Trypanocidal Agents / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D009593:Nitroimidazoles; D014344:Trypanocidal Agents; C009999:benzonidazole