Paediatric postmarketing pharmacovigilance using prescription-event monitoring: Comparison of the adverse event profiles of lamotrigine prescribed to children and adults in England

Drug Safety

Volumn 33, Issue 9, 2010, Pages 751-763

  Aurich Barrera, Beate ^a,b   Wilton, Lynda ^a,b   Brown, David ^a,b   Shakir, Saad ^a,b  

^a DRUG SAFETY RESEARCH UNIT   (United Kingdom)

^b UNIVERSITY OF PORTSMOUTH   (United Kingdom)

Author keywords

adults; adverse reaction monitoring; antiepileptic drugs, adverse reactions; children; lamotrigine, adverse reactions; postmarketing surveillance; prescribing; prescription event monitoring; skin disorders, drug induced; stevens johnson syndrome, drug induced

Indexed keywords

LAMOTRIGINE;

ABDOMINAL PAIN; ABNORMAL BEHAVIOR; ACNE; ADOLESCENT; ADULT; AGE DISTRIBUTION; ANXIETY; ARTICLE; CHILD; CHILD HEALTH CARE; COMPARATIVE STUDY; CONFUSION; CONJUNCTIVITIS; CONVULSION; DEATH; DEPRESSION; DROWSINESS; DRUG MONITORING; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; GASTROENTERITIS; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; INCIDENCE; LASSITUDE; MAJOR CLINICAL STUDY; MALAISE; MALE; MIGRAINE; NAUSEA; PANIC; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; PRURITUS; RASH; SEDATION; SIDE EFFECT; STEVENS JOHNSON SYNDROME; UNITED KINGDOM; VERRUCA VULGARIS; VISUAL DISORDER; VOMITING; WEIGHT GAIN;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGE FACTORS; ANTICONVULSANTS; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; FEMALE; FOLLOW-UP STUDIES; GREAT BRITAIN; HUMANS; INFANT; MALE; TIME FACTORS; TRIAZINES; YOUNG ADULT;

EID: 77955577653     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11536830-000000000-00000     Document Type: Article

References (40)

1. European Parliament and Council of the European Union.Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004. Official Journal of the European Union: L 378/1 (27.12.2006 a)
2. European Parliament and the Council of the EuropeanUnion. Regulation (EC) No. 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. Official Journal of the European Union: L 378/20 (27.12.2006 b)
3. Committee for Medicinal Products for Human Use. Guide-line on conduct of pharmacovigilance for medicines used by the paediatric population [online]. Available from URL http://www.tga.gov.au/docs/pdf/euguide/phvwp/23591005 en.pdf [Accessed 2010 Jul 20]
4. European Commission. Volume 9A "Pharmacovigilance fordrugs for human use" of the rules governing medicinal products in the European Union; EMEA [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol-9/pdf/vol9a-09-2008.pdf [Accessed 2009 Jan 18]
5. CIOMS/WHO. International guidelines for biomedical researchinvolving human subjects. Geneva: CIOMS/WHO, 2002
6. Royal College of Physicians of London. Guidelines on thepractice of ethics committees in medical research involving human subjects. London: RCP, 1996
7. General Medical Council. Good practice in research [online].Available from URL: http://www.gmc-uk.org/guidance/current/library/research. asp#Projects%20which%20are%20not%20approved%20by%20research%20ethics%20com mittees [Accessed 2009 Jan 18]
8. Shakir S. PEM in the UK. In: Mann RD, Andrews EB,editors. Pharmacovigilance. Chichester: John Wiley & Sons, 2007: 307-316
9. Strom B. Sample size considerations for pharmacoepidemio-logy studies. In: Strom B, editor. Pharmacoepidemiology. Chichester: John Wiley & Sons, 2005: 29-36
10. International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: clinical investigation of medicinal products in the pediatric population, E11, Step 4 [online]. Available from URL: http:// www.ich.org/LOB/media/MEDIA487.pdf [Accessed 2009 Jan 18]
11. Shakir SAW. Causality and correlation in pharma-covigilance. In: Talbot J, Waller P, editors. Stephens' detection of new adverse drug reactions. Chichester: John Wiley & Sons, 2004: 329-343
12. Heeley E, Wilton LV, Shakir SAW. Automated signal gen-eration in prescription-event monitoring. Drug Saf 2002; 25: 423-432
13. GlaxoSmithKline. Lamictal: summary of product character-istics 2009 [online]. Available from URL: http://emc.medicines. org.uk/medicine/4228/SPC/ Lamictal+Combined+Tablets/ [Accessed 2009 Nov 2]
14. Wellcome. Lamictal (lamotrigine) tablets [data sheet].London: Wellcome, 1991
15. Martin RM, Kapoor KV, Wilton LV, et al. Underreportingof suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice: observational study. BMJ 1998; 317: 119-120
16. Mackay FJ, Wilton LV, Pearce GL, et al. Safety of long-term lamotrigine in epilepsy. Epilepsia 1997; 38: 881-886
17. Wellcome. Lamital (lamotrigine) tablets, lamictal (lamo-trigine) dispersible [data sheet]. London: Wellcome, 1994
18. Turner S, Nunn AJ, Fielding K, et al. Adverse drug reac-tions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 1999; 88: 965-968
19. Wong I, Sweis D, Cope J, et al. Paediatric medicines re-search in the UK: how to move forward. Drug Saf 2003; 26: 529-537
20. Campbell AGM, McIntosh N, editors. Forfar and Arneil'stextbook of paediatrics. Edinburgh: Churchill Livingstone, 1998
21. Wong IC, Mawer GE, Sander JW. Factors influencing theincidence of lamotrigine-related skin rash. Ann Pharma-cother 1999; 33: 1037-1042
22. Armijo JA, Bravo J, Cuadrado A, et al. Lamotrigine serumconcentration-to- dose ratio: influence of age and concomitant antiepileptic drugs and dosage implications. Ther Drug Monit 1999; 21: 182-190
23. Burton ME, Shaw LM, Schentag JJ, et al. Special pharmaco-kinetic considerations in children. In: Evans WE, Schentag JJ, Jusko WJ, et al., editors. Applied pharmacokinetics and phar-macodynamics: principles of therapeutic drug monitoring. Baltimore (MD): Lippincot, Williams and Wilkins, 2006: 10-32
24. Messenheimer JA, Giorgi L, Risner ME. The tolerability oflamotrigine in children. Drug Saf 2000; 22: 303-1226.
25. Goa KL, Ross SR, Chrisp P. Lamotrigine: a review of itspharmacological properties and clinical efficacy in epilepsy. Drugs 1993; 46: 152-176
26. Vittorio CC, Muglia JJ. Anticonvulsant hypersensitivitysyndrome. Arch Intern Med 1995; 155: 2285-2290
27. Wolkenstein P, Revuz J. Drug-induced severe skin reactions:incidence, management and prevention. Drug Saf 1995; 13: 56-68
28. Schaub JE, Williamson PJ, Barnes EW, et al. Multisystemadverse reaction to lamotrigine [letter]. Lancet 1994; 344: 481
29. Schaub N, Birchloer AJ. Severe hypersensitivity syndrome tolamotrigine confirmed by lymphocyte stimulation in vitro. Allergy 2000; 55: 191-193
30. Carroll MC, Yueng-Yue KA, Essterly NB, et al. Drug-induced hypersensitivity syndrome in pediatric patients. Pediatrics 2001; 108: 485-492
31. Sourander A, Haavisto A, Ronning JA, et al. Behaviouraleffects of the newer antiepileptic drugs: an update. Expert Opin Drug Saf 2004; 3: 1-8
32. Besag FM. Behavioural effects of the newer antiepilepticdrugs: an update. Expert Opin Drug Saf 2004; 3: 1-8
33. Gilliam FG, Santos J, Vahle V, et al. Depression in epilepsy:ignoring clinical expression of neuronal network dysfunction? Epilepsia 2004; 45: 28-33
34. Kaindl AM, Asimiadou S, Manthey D, et al. Antiepilepticdrugs and the developing brain. Cell Mol Life Sci 2006; 63: 399-413
35. Berg AT, Shinnar S, Testa FM, et al. Mortality in child-hood-onset epilepsy. Arch Pediatr Adolesc Med 2004; 158 (12): 1147-1152
36. Nilsson L, Tomson T, Farahmand BY, et al. Cause-specificmortality in epilepsy: a cohort study of more than 9000 patients once hospitalized for epilepsy. Epilepsia 1997; 38 (10): 1062-1068
37. Rafnsson V, Olafsson E, Hauser WA, et al. Cause-specificmortality in adults with unprovoked seizures: a population-based incidence cohort study. Neuroepidemiology 2001; 20 (4): 232-236
38. Mendez MF, Lanska DJ, Manon-Espaillat R, et al. Causa-tive factors for suicide attempts by overdose in epileptics. Arch Neurol 1989; 46 (10): 1065-1068
39. Boerus LO. Drug-receptor interactions and biologic ma-turation. In: Mirkin BL, editor. Clinical pharmacology and therapeutics. Chicago (IL): Year Book Medical Publishers Inc, 1978: 3-22
40. Impicciatore P, Choonara I, Clarkson A, et al. Incidence ofadverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001; 52: 77-83