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Adverse drug reactions in children and adolescents on daily antitubercular regimen: An observational longitudinal

Anurag Agarwal1, Sharadhi H B1, Surendra Bahadur Mathur1

  • 1Department of Pediatrics, Maulana Azad Medical College & Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi, 110002, India.

The Indian Journal of Tuberculosis
|December 18, 2023
PubMed

Insights

The daily fixed-dose combination antitubercular therapy (ATT) regimen increased adverse drug reactions (ADRs) in children, particularly hepatobiliary issues. Malnutrition was a significant risk factor for increased ADR incidence and severity.

Area of Science:

  • Pediatric Pharmacology
  • Infectious Disease Management
  • Clinical Toxicology

Background:

  • India introduced a daily fixed-dose combination (FDC) regimen for antitubercular therapy (ATT) with increased dosages and ethambutol in the continuation phase.
  • This change aimed to simplify treatment but necessitated an evaluation of potential adverse drug reactions (ADRs) in pediatric populations.

Purpose of the Study:

  • To evaluate the incidence and severity of adverse drug reactions (ADRs) in children and adolescents receiving the new daily FDC ATT regimen.
  • To identify specific organ systems affected and risk factors associated with ADRs.

Main Methods:

  • A longitudinal observational study was conducted in a tertiary teaching hospital.
  • Included were 99 children (1 month-18 years) with newly diagnosed drug-sensitive tuberculosis on the daily FDC ATT regimen.
  • Follow-up occurred at 2 weeks, 8 weeks, and 6 months, with ADRs assessed using DAIDS severity grading and WHO-UMC causality.

Main Results:

  • 29 out of 99 participants experienced ADRs, most commonly affecting the hepatobiliary (11.1%) and gastrointestinal (8.1%) systems.
  • Grade 3 severity ADRs were observed in 35.5% of cases, with 19.3% classified as having certain causality.
  • ADRs were significantly more frequent (40.5% vs. 21.1%) and severe (64.7% vs. 0% for Grade 3) in malnourished children.

Conclusions:

  • The introduction of the daily FDC ATT regimen has led to an increased incidence and severity of ADRs in pediatric patients.
  • Hepatobiliary adverse events were the most frequently observed.
  • Malnutrition and low weight-for-age emerged as significant risk factors for both the occurrence and severity of ADRs.
Abstract

Keywords:
MonitoringPediatricPharmacovigilanceSide effectsTuberculosis

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