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.

A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

“…According to Singh et al, Distribution of ADRs across therapeutic classes were Antimicrobials (28.57%), antihypertensive's (24.02%), anti-diabetics (14.28%), and NSAIDs (9.74%). [30][31][32] According to Tiwari et al, gastrointestinal system (73%) was found to be the most commonly affected organ system, followed by the metabolic (17%), cutaneous system (5%), haematological system (3%) and cardiovascular system (2%). 21 In our study also it was quite evident that GI (38%), ADRs are the highest followed by dermatologic (23.3%), metabolic (9.33%), CNS (8%), CVS (7.3%), renal (4%) and musculoskeletal (1.33%).…”

A questionnaire based study of adverse drug effects of antiepileptic drugs in a tertiary care hospital in Central India

“…The finding that CNS related ADRs is maximum correlates with other studies. 9,21 Headache (82.35%) was maximum reported symptom followed by drowsiness which was unlike other study conducted by Suman et al where sedation was the most frequent ADR i.e. 11.2% of total ADRs.…”

“…11.2% of total ADRs. 9 This difference in CNS related symptoms can be due to the variation in study population and site.…”

“…8 AEDs have multifaceted pharmacological properties and narrow therapeutic index, leading to adverse drug reactions (ADRs) which often complicate proper choice of medication, requiring subsequent adjustment of therapy. 9 The target of therapy should be full control of seizures with minimal or no adverse reactions attributed to medications to lead an optimal quality of life. 10 ADRs deteriorates usual life style which can range from mild appetite and behavioural change to serious related problems like losing control over own actions and tremors, ineffective response when required.…”

Comparative Effect of Divided Doses of Adult Solid and Liquid Oral Formulations of Antiepileptic Drugs in the Management of Pediatric Epilepsy

“…A study conducted in the North India by Suman and Gosavi reported similar finding. [ 23 ] Interestingly, both of these tablets were special dosage forms (enteric and film-coated).…”