Adverse Events After the Use of Benznidazole in Infants and Children With Chagas Disease

  title={Adverse Events After the Use of Benznidazole in Infants and Children With Chagas Disease},
  author={Jaime Altcheh and Guillermo Moscatelli and Samanta Moroni and Facundo Garcia-Bournissen and H{\'e}ctor L. Freilij},
  pages={e212 - e218}
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… 
Safety of benznidazole use in the treatment of chronic Chagas' disease.
The Naranjo algorithm was a useful tool to reduce the underreporting of adverse drug reactions in adult patients with chronic Chagas' disease and benznidazole treatment was considered safe.
Tolerance to nifurtimox and benznidazole in adult patients with chronic Chagas’ disease
Current recommended drug regimens for Chagas’ disease are not well tolerated and entail frequent treatment discontinuation irrespective of the drug used, which highlights the need to improve treatment tolerance in adults with ChagAs' disease with new therapeutic options.
A Clinical Adverse Drug Reaction Prediction Model for Patients with Chagas Disease Treated with Benznidazole
The logistic regression models to predict ADRs to BZN described in this study may become important tools to minimize ADRs and improve patients' compliance and thus assist physicians treating patients with Chagas disease with BZn.
Risk factors for treatment interruption and severe adverse effects to benznidazole in adult patients with Chagas disease
Dose, severity of ADRs, eosinophilia and female sex were the main predictors for treatment interruption or severe ADRs.
Population Pharmacokinetic Study of Benznidazole in Pediatric Chagas Disease Suggests Efficacy despite Lower Plasma Concentrations than in Adults
Observed benznidazole plasma concentrations in children were markedly lower than those previously reported in adults (treated with comparable mg/kg doses), possibly due to a higher CL/F in smaller children, which was associated to a high therapeutic response in this cohort.
Long-term comparative pharmacovigilance of orally transmitted Chagas disease: first report
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.
Evaluation of compliance to congenital Chagas disease treatment: results of a randomised trial in Bolivia.
The study confirmed the efficacy and good tolerance of both benznidazole regimens in the treatment of congenital Chagas disease and suggested the short treatment should be preferred as it allows reducing the dose of benznodazole as well as the cost of treatment.
The Clinical and Parasitologic Follow-up of Trypanosoma cruzi–infected Children in a Nonendemic Country
Effectiveness and safety of treatment were optimum in ≤1-year-old children, and increased side effects, cardiac and/or digestive disorder incidence and lower treatment effectiveness were detected in older children, highlighting the need for early screening.
Antitrypanosomal therapy for chronic Chagas' disease.
Significant lower blood concentrations of the drug in children than those reported in adults receiving the same dose per kilogram of body weight are observed, suggesting that lower clearance of benznidazole in adults leads to drug accumulation and a higher rate of adverse events.
Safety Profile of Benznidazole in the Treatment of Chronic Chagas Disease: Experience of a Referral Centre and Systematic Literature Review with Meta-Analysis
Benznidazole had a poor tolerability profile, with a high incidence of TDs, especially in adult patients and women, and optimised dosing schedules and/or new drugs are urgently needed.


Side effects of benznidazole as treatment in chronic Chagas disease: fears and realities
The efficacy and tolerance of benznidazole is inversely related to the age of the patient, while its side effects are more frequent in elderly patients, which means that the true clinical impact of the side effects could be different.
Efficacy of chemotherapy with benznidazole in children in the indeterminate phase of Chagas' disease.
An early serologic marker of cure after treatment, consisting of a recombinant antigen implemented in a rapid, conventional serologic procedure, is used in seropositive children six to 12 years of age.
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  • H. Freilij, J. Altcheh
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The diagnostic and clinical aspects of congenital Chagas' disease were studied in 71 children in Buenos Aires; three children were coinfected with human immunodeficiency virus; the latter infection was severe in two instances.
Evolutive behavior towards cardiomyopathy of treated (nifurtimox or benznidazole) and untreated chronic chagasic patients.
Despite treated patients showed a better clinical evolution and lower antibody levels than untreated ones, it is necessary to carry on doing research in order to improve therapeutic guidelines, according to the risk/benefit equation and based on scientific and ethical principles.
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Clinical and epidemiological results of 95 treated and untreated chronic chagasic children, with an up to 24 years follow-up period are presented, finding that the percentage of treated children presenting negative serological results decrease according to the age when treatment was given, while patients treated in the 7/14 age bracket, the median of negativization was 8 years.
Pediatric Clinical Pharmacology Studies in Chagas Disease
A pharmacokinetics study of benznidazole in a pediatric population with Chagas disease is set out to allow better estimation of the optimal doses and schedule of pharmacotherapy for ChagAs disease in children.
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The preliminary results of a technique that detects the anti F2/3 antibodies are exhibited that would be able to confirm the cure earlier than conventional serology, and the time of negativization between conventionalserology and anti F1/3 in 21 children is compared.
Etiological treatment in patients infected by Trypanosoma cruzi: experiences in Argentina
It seems plausible that trypanocidal therapy may delay, reduce or prevent the progression to the disease, and research priorities should target obtaining new drugs to allow shorter treatments with fewer adverse reactions and improving new tools to confirm cure when patients are treated during the Chronic Phase.