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Pediatrics. 2011 Jan;127(1):e212-8. doi: 10.1542/peds.2010-1172. Epub 2010 Dec 20.

Adverse events after the use of benznidazole in infants and children with Chagas disease.

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  • 1Servicio de Parasitología y Enfermedad de Chagas, Hospital de Niños R. Gutierrez, Gallo 1330, Buenos Aires 1425, Argentina. jaltcheh@gmail.com

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.

[PubMed - indexed for MEDLINE]
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