PMID- 26070796
OWN - NLM
STAT- MEDLINE
DCOM- 20160218
LR  - 20220330
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 5
IP  - 6
DP  - 2015 Jun 12
TI  - Safety of lamotrigine in paediatrics: a systematic review.
PG  - e007711
LID - 10.1136/bmjopen-2015-007711 [doi]
LID - e007711
AB  - OBJECTIVES: To identify adverse drug reactions associated with lamotrigine in 
      children and compare the safety profile with other antiepileptic drugs. SETTING: 
      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. PARTICIPANTS: 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. PRIMARY AND SECONDARY OUTCOME 
      MEASURES: 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. TRIAL 
      REGISTRATION NUMBER: CRD42013006910.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://group.bmj.com/group/rights-licensing/permissions.
FAU - Egunsola, Oluwaseun
AU  - Egunsola O
AD  - Academic Division of Child Health, University of Nottingham, Derbyshire 
      Children's Hospital, Derby, UK.
FAU - Choonara, Imti
AU  - Choonara I
AD  - Academic Division of Child Health, University of Nottingham, Derbyshire 
      Children's Hospital, Derby, UK.
FAU - Sammons, Helen M
AU  - Sammons HM
AD  - Academic Division of Child Health, University of Nottingham, Derbyshire 
      Children's Hospital, Derby, UK.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20150612
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Anticonvulsants)
RN  - 0 (Triazines)
RN  - U3H27498KS (Lamotrigine)
SB  - IM
MH  - Abdominal Pain/chemically induced
MH  - Anticonvulsants/administration & dosage/*adverse effects
MH  - Child
MH  - Dizziness/chemically induced
MH  - Drug Therapy, Combination
MH  - Exanthema/chemically induced
MH  - Headache/chemically induced
MH  - Humans
MH  - Lamotrigine
MH  - Nausea/chemically induced
MH  - Triazines/administration & dosage/*adverse effects
MH  - Vomiting/chemically induced
PMC - PMC4466618
EDAT- 2015/06/14 06:00
MHDA- 2016/02/19 06:00
PMCR- 2015/06/12
CRDT- 2015/06/14 06:00
PHST- 2015/06/14 06:00 [entrez]
PHST- 2015/06/14 06:00 [pubmed]
PHST- 2016/02/19 06:00 [medline]
PHST- 2015/06/12 00:00 [pmc-release]
AID - bmjopen-2015-007711 [pii]
AID - 10.1136/bmjopen-2015-007711 [doi]
PST - epublish
SO  - BMJ Open. 2015 Jun 12;5(6):e007711. doi: 10.1136/bmjopen-2015-007711.