Title

Adverse Drug Reactions (ADRs) in children following Antiepileptic Drug (AED) use: part of the Molecular Genetics of Adverse Drug Reactions in Children (MAGIC study)

Lead Investigator

Professor Munir Pirmohamed
NHS Chair of Pharmacogenomics, Wolfson Centre for Personalised Medicine, University of Liverpool

Additional investigators:

Dr. Richard Appleton - Consultant Paediatric Neurologist, Alder Hey Hospital. Dr. Daniel Hawcutt - Lecturer Paediatric Pharmacology, University of Liverpool. Dr. Andrea Jorgensen- Lecturer in Medical Genetics, University of Liverpool

Case Definition

We are interested in any child or young person who has had a suspected Adverse Drug Reaction (ADR) while using an Antiepileptic drug (AED). This ADR could affect any system, and be of any duration or severity. We are particularly interested in mucocutaneous eruptions but are keen to hear about any ADR including changes in behaviour or emotion.

Inclusion Criteria

Case

  • Participant age <16 years of age at time of ADR
  • Diagnosed with ADR (as described in MAGIC protocol section 2.2)
  • Written informed consent obtained from participant (if participant aged >16 years of age at time of recruitment) or from parent/guardian (if participant aged <16 years at time of recruitment)
  • Assent obtained from competent young person (assessed on case-by-case basis)

Control

  • Participant (if aged >16 years at time of recruitment) or parent/guardian (if <16 years of age) willing to take part.
  • Taking the drug in question without the occurrence of ADR (as outlined in the study design section 2.2)
  • Ethnically matched to the index patient
  • Has the same underlying disease as the index patient
  • Recruited from the same practice/specialist clinical area as the index patient
  • Written informed consent from participant (if aged >16 years of age) or parent/guardian (if <16 years old) obtained
  • Assent obtained from competent young person (assessed on case-by-case basis)

Exclusion Criteria

  • Parent/guardian unwilling to take part (if participant <16 years of age at time of recruitment)
  • Participant unwilling to consent (if participant >16 years of age at time of recruitment)
  • Competent older participant unwilling to assent (competence assessed on a case-by-case basis)
  • Patient is, in the opinion of the Investigator, not suitable to participate in the study