Safety of antiepileptic drugs in children and young people: A prospective cohort study

Seizure. 2018 Mar:56:20-25. doi: 10.1016/j.seizure.2018.01.018. Epub 2018 Feb 2.

Abstract

Purpose: This study aims to describe the incidence of adverse drug reactions (ADRs) in children receiving antiepileptic drugs (AEDs) and compare ADRs to the individual drugs when given as monotherapy.

Method: Paediatric patients (≤18 years old) were enrolled for this prospective observational study over a 6-month period, between September 2015 and March 2016. Adverse reactions to antiepileptic drugs (AEDs) were elicited at the time of enrolment and after 3 months using the Paediatric Epilepsy Side Effects Questionnaire.

Results: A total of 1139 suspected ADRs were reported in 124 participants. Eighteen different AEDs were prescribed. Sixty-six children (53%) were receiving AED monotherapy at the time of recruitment; 34/66 (52%) of whom received new generation AEDs. Levetiracetam was the most frequently prescribed AED (62/124, 50%). When only children receiving AED monotherapy were considered, fatigue, drowsiness, weight gain, dizziness were less likely with levetiracetam (p < .01). Slow thinking and decreased concentration were less likely with levetiracetam or carbamazepine than valproic acid (p < .05). Five patients (four on polytherapy) discontinued AED treatment due to ADRs and 2 had a dose reduction.

Conclusions: Levetiracetam and carbamazepine were better tolerated than sodium valproate.

Keywords: Carbamazepine; Epilepsy; Levetiracetam; Paediatrics; Sodium valproate.

MeSH terms

  • Adolescent
  • Anticonvulsants / adverse effects*
  • Carbamazepine
  • Chi-Square Distribution
  • Child
  • Child, Preschool
  • Cohort Studies
  • Epilepsy / drug therapy*
  • Female
  • Humans
  • Levetiracetam
  • Male
  • Piracetam / analogs & derivatives
  • Surveys and Questionnaires
  • Valproic Acid

Substances

  • Anticonvulsants
  • Carbamazepine
  • Levetiracetam
  • Valproic Acid
  • Piracetam