title: Adverse effects of antiepileptic drugs in North Indian pediatric outpatients.
abstract: OBJECTIVE
  The present study investigates the pattern and predictors of treatment-emergent adverse drug reactions (ADRs) in children diagnosed with epilepsy.
  
  
  METHODS
  We conducted prospective observational study in a tertiary care teaching hospital on 277 epileptic children. Antiepileptic drug (AED)-associated ADRs, demographic and clinical characteristics, AED regimen, and so on were recorded. Causality, severity, and preventability were performed by World Health Organization-Uppsala Monitoring Center scale, Hartwig's severity scale, and Schumock and Thornton questionnaire, respectively.
  
  
  RESULTS
  Of the enrolled population, 53% children had symptomatic epilepsy, and 51% were in 5- to 10-year age group. More than two-thirds of children were on monotherapy, with phenytoin (n = 176, 63.5%) being the most common AED. Three hundred fifty-three AED-related ADRs were recorded in 175 children (63.2%). Poor scholastic performance (19%) was the most common ADR, followed by gum hypertrophy (13.3%), headache (10.2%), behavioral problems (5.7%), drowsiness (5.7%), and others. Two hundred sixteen ADRs were probable, and 126 ADRs were possible. Severe ADRs were noted in 6 children. Girls (odds ratio [OR], 1.93; 95% confidence interval [95% CI], 1.07-3.45; P = 0.03), children with secondary epilepsy (OR, 3.31; 95% CI, 1.76-6.23; P ≤ 0.001), children older than 5 years (5-10 years; OR, 6.28; 95% CI, 2.79-14.12; P ≤ 0.001), and those older than 10 years (OR, 9.04; 95% CI, 3.69-22.17; P ≤ 0.001) were found to be at higher risk of experiencing ADRs.
  
  
  CONCLUSIONS
  Monotherapy was the preferred treatment. Phenytoin was the most common ADR causative agent. Female sex, symptomatic epilepsy, and older age (> 5 years) were found to be associated with higher probability of ADR development.
authors.affiliation: Clinical Research Unit, Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, SAS Nagar, Mohali, India. dipikabansal079@gmail.com
authors.forename: Dipika
authors.initials: D
authors.lastname: Bansal
authors.forename: Chandrika
authors.initials: C
authors.lastname: Azad
authors.forename: Manpreet
authors.initials: M
authors.lastname: Kaur
authors.forename: Neelima
authors.initials: N
authors.lastname: Rudroju
authors.forename: Pravallika
authors.initials: P
authors.lastname: Vepa
authors.forename: Vishal
authors.initials: V
authors.lastname: Guglani
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002657:Child Development / Q000187:drug effects; D002675:Child, Preschool; D015331:Cohort Studies; D004359:Drug Therapy, Combination / Q000009:adverse effects; D004827:Epilepsy / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D017029:Epilepsy, Complex Partial / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D004830:Epilepsy, Tonic-Clonic / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D005260:Female; D006801:Humans; D007194:India; D007859:Learning Disabilities / Q000139:chemically induced; D008137:Longitudinal Studies; D008297:Male; D020019:Neurocysticercosis / Q000503:physiopathology; D010672:Phenytoin / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D012727:Sex Characteristics
chemical_list: D000927:Anticonvulsants; D010672:Phenytoin