EVALUATION OF DRUG USE IN HEPATITIS AND ASSOCIATED ADVERSE DRUG REACTIONS IN PEDIATRIC PATIENTS: A PROSPECTIVE OBSERVATIONAL STUDY.
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Keywords
Pediatric hepatitis, adverse drug reactions, DAAs, interferon, pharmacovigilance
Abstract
Background: Hepatitis in children is managed with antivirals, immunomodulators, and supportive therapies, all of which may cause adverse drug reactions (ADRs). Data on pediatric ADRs remain limited in India.
Objective: To evaluate the frequency, severity, onset, and causality of ADRs in pediatric hepatitis patients receiving direct-acting antivirals (DAAs), interferon, and supportive treatments at KGMU, Lucknow.
Methods: A prospective observational study was conducted from March 2024 to March 2025 in Pediatrics and Medicine OPD/IPD at KGMU. Sixty-two children (ages 1–18 years) diagnosed with hepatitis A, B, C, or autoimmune hepatitis were monitored for ADRs. Reactions were assessed using the WHO-UMC causality scale and Hartwig’s severity scale.
Results: ADRs were reported in 14 patients (22.6% incidence). The most common ADRs included diarrhea (35.7%), fever (21.4%), abdominal pain (14.3%), fatigue (14.3%), itching (7.1%), and weight gain with hyperglycemia (7.1%). Most ADRs were mild (Level 1), while diarrhea was rated moderate (Level 2). Causality assessment showed 92.9% as possible and 7.1% as probable. Interferon-based regimens were associated with earlier onset of ADRs compared to DAAs.
Conclusion: ADRs were observed in about 25% of pediatric hepatitis patients, mainly as gastrointestinal symptoms. Most were mild, but some required management. DAAs showed a better safety profile than interferon-based treatments, emphasizing the need for routine monitoring and stronger pharmacovigilance in pediatric hepatology.
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Rahul Soni
MD PHARMACOLOGY, Junior Resident KGMU, Lucknow, UP, India,
Shilpi Biswas
MD PHARMACOLOGY, Junior Resident KGMU, Lucknow, UP, India,
Ayush Jain
MD, DNB PHARMACOLOGY, Assistant Professor, KGMU, Lucknow, UP, India,
Sanjeev Kumar Verma
MD Padiatric, Professor, KGMU, Lucknow, UP, India,
Ajay Kumar Patwa
MD, DM MEDICINE, Professor, KGMU, Lucknow, UP, India, drajaymd12345@gmail.com
Suyog Sindhu
MD PHARMACOLOGY, Associate Professor, KGMU, Lucknow, UP, India,
Narendra Kumar
MD PHARMACOLOGY, Professor, KGMU, Lucknow, UP, India,