Article Text

Download PDFPDF

A prospective study of adverse drug reactions to antiepileptic drugs in children
  1. Mark Anderson1,
  2. Oluwaseun Egunsola1,
  3. Janine Cherrill1,
  4. Claire Millward1,
  5. Apostolos Fakis2,
  6. Imti Choonara1
  1. 1Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK
  2. 2Department of Research and Development, Royal Derby Hospital, Derby, UK
  1. Correspondence to Dr Oluwaseun Egunsola; mzxoe{at}nottingham.ac.uk

Abstract

Objectives 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.

Setting A single centre prospective observational study.

Participants Children (<18 years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit.

Primary and secondary outcomes 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.

Trail registration number EudraCT (2007-000565-37).

  • CLINICAL PHARMACOLOGY

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

View Full Text

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.