title: A prospective study of adverse drug reactions to antiepileptic drugs in children.
abstract: OBJECTIVE
  To prospectively determine the nature and rate of adverse drug reactions (ADRs) in children on antiepileptic drugs (AEDs) and to prospectively evaluate the effect of AEDs on behaviour.
  
  
  METHODS
  A single centre prospective observational study.
  
  
  METHODS
  Children (<18 years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit.
  
  
  METHODS
  Primary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes.
  
  
  RESULTS
  180 children were recruited. Sodium valproate and carbamazepine were the most frequently used AEDs. A total of 114 ADRs were recorded in 56 of these children (31%). 135 children (75%) were on monotherapy. 27 of the 45 children (60%) on polytherapy had ADRs; while 29 (21%) of those on monotherapy had ADRs. The risk of ADRs was significantly lower in patients receiving monotherapy than polytherapy (RR: 0.61, 95% CI 0.47 to 0.79, p<0.0001). Behavioural problems and somnolence were the most common ADRs. 23 children had to discontinue their AED due to an ADR.
  
  
  CONCLUSIONS
  Behavioural problems and somnolence were the most common ADRs. Polytherapy significantly increases the likelihood of ADRs in children.
  
  
  BACKGROUND
  EudraCT (2007-000565-37).
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Anderson
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Oluwaseun
authors.initials: O
authors.lastname: Egunsola
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Janine
authors.initials: J
authors.lastname: Cherrill
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Millward
authors.affiliation: Department of Research and Development, Royal Derby Hospital, Derby, UK.
authors.forename: Apostolos
authors.initials: A
authors.lastname: Fakis
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Imti
authors.initials: I
authors.lastname: Choonara
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects*; D002220:Carbamazepine / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003072:Cognition Disorders / Q000139:chemically induced*; D004359:Drug Therapy, Combination / Q000009:adverse effects*; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index; D020919:Sleep Disorders, Intrinsic / Q000209:etiology; D014227:Triazines / Q000008:administration & dosage / Q000009:adverse effects*; D006113:United Kingdom / Q000453:epidemiology; D014635:Valproic Acid / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000927:Anticonvulsants; D014227:Triazines; D002220:Carbamazepine; D014635:Valproic Acid; D000077213:Lamotrigine
keywords: CLINICAL PHARMACOLOGY