title: Safety of lamotrigine in paediatrics: a systematic review.
abstract: OBJECTIVE
  To identify adverse drug reactions associated with lamotrigine in children and compare the safety profile with other antiepileptic drugs.
  
  
  METHODS
  Databases EMBASE (1974-April 2015), MEDLINE (1946-April 2015), PubMed and the Cochrane library for randomised controlled trials were searched for studies on safety of lamotrigine.
  
  
  METHODS
  All studies involving paediatric patients aged ≤ 18 years who have received at least a single dose of lamotrigine with safety as an outcome measure were included.
  
  
  METHODS
  The primary outcome measure was safety of lamotrigine. Drug interaction of lamotrigine was the secondary outcome.
  
  
  RESULTS
  A total of 78 articles involving 3783 paediatric patients were identified. There were 2222 adverse events (AEs) reported. Rash was the most commonly reported AE, occurring in 7.3% of the patients. Stevens-Johnson syndrome was rarely reported, with a risk of 0.09 per 100 patients. Discontinuation due to an adverse drug reaction (ADR) was recorded in 72 children (1.9% of all treated patients). Fifty-eight per cent of treatment discontinuation was attributed to different forms of rash and 21% due to increased seizures. Children on lamotrigine monotherapy had lower incidences of AEs. Headache (p=0.02), somnolence (<0.001), nausea (p=0.01), vomiting (p<0.001), dizziness (p<0.001) and abdominal pain (p=0.01) were significantly lower among children on monotherapy.
  
  
  CONCLUSIONS
  Rash was the most common ADR of lamotrigine and the most common reason for treatment discontinuation. Children receiving polytherapy have a higher risk of AEs than monotherapy users.
  
  
  BACKGROUND
  CRD42013006910.
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: Imti
authors.initials: I
authors.lastname: Choonara
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Helen M
authors.initials: HM
authors.lastname: Sammons
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D004244:Dizziness / Q000139:chemically induced; D004359:Drug Therapy, Combination; D005076:Exanthema / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D000077213:Lamotrigine; D009325:Nausea / Q000139:chemically induced; D014227:Triazines / Q000008:administration & dosage / Q000009:adverse effects*; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000927:Anticonvulsants; D014227:Triazines; D000077213:Lamotrigine