A Study of Adverse Drug Reactions to Antiepileptic Drugs in Pediatric Epileptic Patients From North India.

OBJECTIVES: The primary objective of this study was to evaluate the various adverse drug reactions (ADRs) associated with antiepileptic drugs in children. The secondary objective was to analyze the distribution of these ADRs according to gender, age group, type of epilepsy, and treatment modality. MATERIALS AND METHODS: An observational cross-sectional study was conducted in the pediatric outpatient department of a tertiary care hospital. A total of 100 eligible patients, who fulfilled the inclusion and exclusion criteria, were enrolled in the study after obtaining informed consent. The prescription details and ADRs were collected using a pre-designed proforma and the Pediatric Epilepsy Side-effect Questionnaire, respectively. The collected data were then analyzed using descriptive statistics and the chi-square test, where appropriate. The p-value <0.05 was considered statistically significant. RESULTS: A total of 67 ADRs were reported in 42 participants, predominantly in males (71.43%). Polytherapy (75%) was associated with a higher number of ADRs (p=0.002). Patients treated with valproate (monotherapy group) and valproate with clobazam (polytherapy group) reported a greater number of ADRs (57.14%, 72.73%). CONCLUSIONS: The study highlights that ADRs are more common in patients on conventional drugs like valproate, either as monotherapy or polytherapy. Use of newer drugs by physicians and reporting of ADRs by patients should be encouraged for the comprehensive management of childhood epilepsy.