Adverse drug reactions to antiseizure medications in pediatric epilepsy: a pharmacovigilance study from a tertiary care centre in India

Abstract

Background: Epilepsy is a chronic neurological disorder requiring long term antiseizure drug (ASD) therapy, often associated with adverse drug reactions (ADRs). Understanding the frequency and nature of ADRs in pediatric patients is essential for optimizing treatment outcomes. Objectives of the study were to evaluate the prevalence, pattern, and causality of ADRs associated with antiseizure drugs in pediatric patients using the Naranjo scale and World Health Organization-Uppsala monitoring centre (WHO UMC) causality assessment system.

Methods: A descriptive cross-sectional study was conducted over 12 months in the Departments of Pharmacology and Paediatrics at Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. Pediatric epilepsy patients (1–12 years) on antiseizure drugs for ≥1 month were enrolled. ADRs were recorded using the Central Drugs Standard Control Organization (CDSCO) ADR reporting form and assessed using Naranjo and WHO UMC scales. Descriptive statistics were used for data analysis.

Results: Among 196 enrolled patients, 39 (20%) experienced ADRs. The most common ADRs were sedation (10.2%), gum hypertrophy (5.1%), constipation (4.6%), vomiting (4.1%), nausea (4.1%), rash (3.6%), and abdominal pain (3.6%). Causality assessment showed 56.42% of ADRs were probable and 43.58% were possible using both the Naranjo and WHO UMC scales.

Conclusions: ADRs to antiseizure drugs are common in pediatric patients, with sedation being the most frequent. Most ADRs were of probable or possible causality. Regular monitoring and early recognition can improve treatment outcomes and quality of life.