Safety of lamotrigine in paediatrics: A systematic review

BMJ Open

Volumn 5, Issue 6, 2015, Pages

  Egunsola, Oluwaseun ^a   Choonara, Imti ^a   Sammons, Helen M ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

LAMOTRIGINE; ANTICONVULSIVE AGENT; TRIAZINE DERIVATIVE;

ABDOMINAL PAIN; AGGRESSION; AMNESIA; ANOREXIA; ANXIETY DISORDER; APNEA; ARTICLE; ASTHENIA; ATAXIA; ATTENTION DISTURBANCE; CONCENTRATION LOSS; CONSTIPATION; COUGHING; DEPRESSION; DIARRHEA; DISEASE EXACERBATION; DISORIENTATION; DIZZINESS; DROWSINESS; DRUG SAFETY; DRUG WITHDRAWAL; EAR DISEASE; EAR INFECTION; FATIGUE; FEVER; HEADACHE; HOSTILITY; HUMAN; HYPERACTIVITY; HYPERKINESIA; INCREASED APPETITE; INSOMNIA; IRRITABILITY; LETHARGY; MONOTHERAPY; NAUSEA; NOSE OBSTRUCTION; NYSTAGMUS; OUTCOME ASSESSMENT; PARESTHESIA; PEDIATRICS; PERSONALITY DISORDER; RASH; RESPIRATORY TRACT INFECTION; RHINOPHARYNGITIS; RISK ASSESSMENT; SEIZURE; SINGLE DRUG DOSE; SOMNOLENCE; STEVENS JOHNSON SYNDROME; SUICIDE ATTEMPT; SYSTEMATIC REVIEW; TREMOR; VOMITING; WHEEZING; CHEMICALLY INDUCED; CHILD; COMBINATION DRUG THERAPY; META ANALYSIS;

ABDOMINAL PAIN; ANTICONVULSANTS; CHILD; DIZZINESS; DRUG THERAPY, COMBINATION; EXANTHEMA; HEADACHE; HUMANS; NAUSEA; TRIAZINES; VOMITING;

EID: 84937249974     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-007711     Document Type: Article

References (43)

1. Weisler RH, Calabrese JR, Bowden CL, et al. Discovery and development of lamotrigine for bipolar disorder: a story of serendipity, clinical observations, risk taking, and persistence. J Affect Disord 2008;108:1-9.
2. Ackers R, Murray ML, Besag F, et al. Prioritizing children's medicines for research: a pharmacoepidemiological study of antiepileptic drugs. Br J Clin Pharmacol 2007;63:689-97.
3. Van de Vrie-Hoekstra NW, De Vries TW, Van den Berg PB, et al. Antiepileptic drug utilization in children from 1997-2005 - a study from the Netherlands. Eur J Clin Pharmacol 2008;64:1013-20.
4. National Institute for Health and Clinical Excellence. The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care. 2012 guidance.nice.org.uk/cg137 (accessed 9 Dec 2013).
5. Armijo JA, Bravo J, Cuadrado A, et al. Lamotrigine serum concentration-to-dose ratio: influence of age and concomitant antiepileptic drugs and dosage implications. Ther Drug Monit 1999;21:182-90.
6. Messenheimer J. Efficacy and safety of lamotrigine in pediatric patients. J Child Neurol2002;17(Suppl 2):2S34-42.
7. Guberman AH, Besag F, Brodie MJ, et al. Lamotrigine-associated rash: risk/benefit considerations in adults and children. Epilepsia 1999;40:985-91.
8. Guerrini R, Dravet C, Genton P, et al. Lamotrigine and seizure aggravation in severe myoclonic epilepsy. Epilepsia 1998;39:508-12.
9. Higgins JP, Altman DG, Gøtzsche PC, et al., Cochrane Statistical Methods Group. The cochrane collaboration's tool for assessing risk of bias in randomised trials. BMJ2011;343:d5928.
10. The Joanna Briggs Institute. System for the Unified Management of the Review and Assessment of Information (SUMARI). 2004. http://www.joannabriggs.org/assets/docs/sumari/SUMARI-V5-User-guide.pdf (accessed 8 Oct 2014).
11. Piña-Garza JE, Elterman RD, Ayala R, et al. Long-term tolerability and efficacy of lamotrigine in infants 1 to 24 months old. J Child Neurol 2008;23:853-61.
12. Besag F, Wallace S, Dulac O, et al. Lamotrigine for the treatment of epilepsy in childhood. J Pediatr 1995;127:991-7.
13. Mikati MA, Fayad M, Koleilat M, et al. Efficacy, tolerability, and kinetics of lamotrigine in infants. J Pediatr 2002;141:31-5.
14. Thome-Souza S, Valente KD. Valproate and lamotrigine in pediatric patients with refractory epilepsy: after the first year. Pediatr Neurol 2013;48:436-42.
15. Fallah R, Akhavan KS, Golestan M. Efficacy and safety of lamotrigine in lennox-Gastaut syndrome. Iran J Child Neurol2009;3:33-8.
16. Duchowny M, Gilman J, Messenheimer J, et al. Long-term tolerability and efficacy of lamotrigine in pediatric patients with epilepsy. J Child Neurol2002;17:278-85.
17. Barzegar M, Tonekaboni SH, Ghofrani M. lamotrigine as add on therapy in children with drug resistant epilepsy. Med J Islamic 2003;17:15-8.
18. Coppola G, Pascotto A. Lamotrigine as add-on drug in children and adolescents with refractory epilepsy and mental delay: an open trial. Brain Dev 1997;19:398-402.
19. Farrell K, Connolly MB, Munn R, et al. Prospective, open-label, add-on study of lamotrigine in 56 children with intractable generalized epilepsy. Pediatr Neurol1997;16:201-5.
20. Besag FM, Dulac O, Alving J, et al. Long-term safety and efficacy of lamotrigine (Lamictal) in paediatric patients with epilepsy. Seizure 1997;6:51-6.
21. Holmes GL, Frank LM, Sheth RD, et al. Lamotrigine monotherapy for newly diagnosed typical absence seizures in children. Epilepsy Res 2008;82:124-32.
22. Mackay FJ, Wilton LV, Pearce GL, et al. Safety of long-term lamotrigine in epilepsy. Epilepsia 1997;38:881-6.
23. Frank LM, Enlow T, Holmes GL, et al. Lamictal (lamotrigine) monotherapy for typical absence seizures in children. Epilepsia 1999;40:973-9.
24. Glauser TA, Cnaan A, Shinnar S, et al. Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy. N Engl J Med 2010;362:790-9.
25. Duchowny M, Pellock J, Graf W, et al. A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children. Neurology 1999;53:1724-31.
26. Pina-Garza J, Levisohn P, Gucuyener K, et al. Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months. Neurology 2008;70(22 Part 2):2099-108.
27. Eriksson AS, Nergårdh A, Hoppu K. The efficacy of lamotrigine in children and adolescents with refractory generalized epilepsy: a randomized, double-blind, crossover study. Epilepsia 1998;39:495-501.
28. Trevathan E, Kerls SP, Hammer AE, et al. Lamotrigine adjunctive therapy among children and adolescents with primary generalized tonic-clonic seizures. Pediatrics 2006;118:e371-8.
29. Coppola G, Auricchio G, Federico R, et al. Lamotrigine versus valproic acid as first-line monotherapy in newly diagnosed typical absence seizures: an open-label, randomized, parallel-group study. Epilepsia 2004;45:1049-53.
30. Nieto-Barrera M, Brozmanova M, Capovilla G, et al. A comparison of monotherapy with lamotrigine or carbamazepine in patients with newly diagnosed partial epilepsy. Epilepsy Res 2001;46:145-55.
31. Ohtahara S, Iinuma K, Fujiwara T. Single-blind controlled comparative study of lamotrigine with zonisamide for refractory pediatric epilepsy. Jpn Epilepsy Soc 2008;25: 425-40.
32. Messenheimer JA, Giorgi L, Risner ME. The tolerability of lamotrigine in children. Drug Saf 2000;22:303-12.
33. Hirsch LJ, Weintraub DB, Buchsbaum R, et al. Predictors of Lamotrigine-associated Rash. Epilepsia 2006;47:318-22.
34. Harr T, French LE. Toxic epidermal necrolysis and Stevens-Johnson syndrome. Orphanet J Rare Dis 2010;5:39.
35. Paediatric Formulary Committee. BNF for children (online). London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. http://www.medicinescomplete.com (accessed 15 Nov 2014).
36. Food and Drug Administration. Lamictal: full prescribing information. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM235547.pdf (accessed 13 Jan 2015).
37. Zaccara G, Franciotta D, Perucca E. Idiosyncratic adverse reactions to antiepileptic drugs. Epilepsia 2007;48:1223-44.
38. Shi YW, Min FL, Liu XR, et al. HLA-B alleles and lamotrigine-induced cutaneous adverse drug reactions in Han Chinese population. Basic Clin Pharmacol Toxicol 2011;109:42-6.
39. Anderson GD, Yau MK, Gidal BE, et al. Bidirectional interaction of valproate and lamotrigine in healthy subjects. Clin Pharmacol Ther 1996;60:145-56.
40. Baker GA, Jacoby A, Buck D, et al. Quality of life of people with epilepsy: a European study. Epilepsia 1997;38:353-62.
41. Elger CE, Bauer J, Scherrmann J, et al. Aggravation of focal epileptic seizures by antiepileptic drugs. Epilepsia 1998;39(Suppl 3): S15-18.
42. Pal A, Prusty SK, Sahu PK, et al. drug utilization pattern of antiepileptic drugs: a pharmacoepidemiologic and pharmacovigilance study in a tertiary teaching hospital in India. Asian J Pharm Clin Res 2011;4:96-9.
43. Star K, Edwards IR, Choonara I. Valproic acid and fatalities in children: a review of individual case safety reports in VigiBase. PLoS ONE 2014;9:e108970.