Study of adverse drug effects of antiepileptic drugs used in pediatric patients in a tertiary care rural hospital – a Pharmacovigilance study

Abstract

: Objective: To assess the prescription pattern & Adverse Drug Reaction (ADR)) profile of Antiepileptic drug (AEDs) therapy in children of rural population. Materials and Methods: This prospective open label, observational study was carried out over one and half year duration on 142 newly diagnosed epileptic children below 12 yrs age receiving AEDs in pediatric department in a tertiary care rural hospital. Follow up was done every month for 6 months duration. Prescription pattern and incidence, causality and severity of ADRs due to AEDs were assessed at each visit. Results: Out of 142 patients on AEDs, 97.2% patients were on mono-therapy and 2.8% patients were on poly-therapy. Valproic acid was the most commonly prescribed drug (58) and Lorazepam was the least prescribed drug (1). Central nervous system related ADRs (50%) were most common followed by gastrointestinal system (14.7%). Sedation and gastrointestinal distress were among the most frequently reported ADRs and29.4% of probable category while 70.5% ADR’s were possible category. 72% ADRs were mild, 22% were moderate and 5.8% of ADRs were severe. Conclusions: Children receiving AEDs should be closely monitored for the development of any ADRs, especially related to their behavior and cognition. as it can influence their learning and memory, Active surveillance can help in knowing the exact incidence of ADRs. This study emphasizes on the role of patient / parent education and importance of health care professionals in pharmacovigilance studies.Key words: Adverse Drug Reactions, Antiepileptic Drugs, Pharmacovigilance