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. PATIENTS AND 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.

journal_name

Pediatrics

journal_title

Pediatrics

authors

Altcheh J,Moscatelli G,Moroni S,Garcia-Bournissen F,Freilij H

doi

10.1542/peds.2010-1172

subject

Has Abstract

pub_date

2011-01-01 00:00:00

pages

e212-8

issue

1

eissn

0031-4005

issn

1098-4275

pii

peds.2010-1172

journal_volume

127

pub_type

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