A prospective study of adverse drug reactions to antiepileptic drugs in children

BMJ Open

Volumn 5, Issue 6, 2015, Pages

  Anderson, Mark ^a   Egunsola, Oluwaseun ^a   Cherrill, Janine ^a   Millward, Claire ^a   Fakis, Apostolos ^b   Choonara, Imti ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^b ROYAL DERBY HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; CLOBAZAM; CLONAZEPAM; ETHOSUXIMIDE; ETIRACETAM; GABAPENTIN; LAMOTRIGINE; NITRAZEPAM; OXCARBAZEPINE; PARALDEHYDE; PHENOBARBITAL; PHENYTOIN; VALPROIC ACID; TRIAZINE DERIVATIVE;

ABDOMINAL PAIN; ADVERSE DRUG REACTION; ANXIETY DISORDER; ARTICLE; ASSESSMENT OF HUMANS; AUDITORY HALLUCINATION; BEHAVIOR DISORDER; BLURRED VISION; CHILD; CHILD BEHAVIOR CHECKLIST; CHILDHOOD DISEASE; COGNITION; DEPRESSION; DIARRHEA; DIZZINESS; DROWSINESS; DRUG ERUPTION; DRUG FEVER; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; DYSTONIA; ENURESIS; EPILEPSY; EPISTAXIS; FATIGUE; FOLLOW UP; GROUPS BY AGE; GUM HYPERTROPHY; HAIR LOSS; HEADACHE; HUMAN; HYPERTROPHY; INCONTINENCE; LIMIT OF QUANTITATION; LOSS OF APPETITE; MAJOR CLINICAL STUDY; MONOTHERAPY; NAUSEA; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; POLYDIPSIA; PROSPECTIVE STUDY; RESPIRATORY ARREST; SEIZURE; SIDE EFFECT; SOMNOLENCE; STEVENS JOHNSON SYNDROME; THROMBOCYTOPENIA; TREMOR; VOMITING; WECHSLER INTELLIGENCE SCALE; YOUTH SELF REPORT FORM; ADOLESCENT; ADVERSE EFFECTS; CHEMICALLY INDUCED; COGNITIVE DEFECT; COMBINATION DRUG THERAPY; EPIDEMIOLOGY; FEMALE; MALE; PRESCHOOL CHILD; SEVERITY OF ILLNESS INDEX; SLEEP DISORDERS, INTRINSIC; UNITED KINGDOM;

ADOLESCENT; ANTICONVULSANTS; CARBAMAZEPINE; CHILD; CHILD, PRESCHOOL; COGNITION DISORDERS; DRUG THERAPY, COMBINATION; EPILEPSY; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; PROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; SLEEP DISORDERS, INTRINSIC; TRIAZINES; UNITED KINGDOM; VALPROIC ACID;

EID: 84931267023     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-008298     Document Type: Article

References (40)

1. Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001;52:77-83.
2. Clavenna A, Bonati M. Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child 2009;94:724-8.
3. Bárzaga AZ, López LA, Mejías PY, et al. Pharmacovigilance in children in Camagüey Province, Cuba. Eur J Clin Pharmacol 2012;68:1079-84.
4. Choonara IA. Anticonvulsant toxicity in paediatric outpatients. Br J Clin Pract 1988;42:21-3.
5. Clarkson A, Choonara I. Surveillance for fatal suspected adverse drug reactions in the UK. Arch Dis Child 2002;87:462-7.
6. Le J, Nguyen T, Law AV, et al. Adverse drug reactions among children over a 10-year period. Pediatrics 2006;118:555-62.
7. Wong ICK, Lhatoo SD. Adverse reactions to new anticonvulsant drugs. Drug Saf 2000;23:35-56.
8. Anderson M, Choonara I. A systematic review of safety monitoring and drug toxicity in published randomised controlled trials of antiepileptic drugs in children over a 10-year period. Arch Dis Child 2010;95:731-8.
9. Bailet LL, Turk WR. The impact of childhood epilepsy on neurocognitive and behavioral performance: a prospective longitudinal study. Epilepsia 2000;41:426-31.
10. Aldenkamp AP. Effects of antiepileptic drugs on cognition. Epilepsia 2001;42(s1):46-9.
11. Brunbech L, Sabers A. Effect of antiepileptic drugs on cognitive function in individuals with epilepsy. Drugs 2002;62:593-604.
12. Weintraub D, Buchsbaum R, Resor S Jr, et al. Psychiatric and behavioural side effects of the newer antiepileptic drugs in adults with epilepsy. Epilepsy Behav 2007;10:105-10.
13. Drane DL, Meador KJ. Cognitive and behavioral effects of antiepileptic drugs. Epilepsy Behav 2002;3(5S):49-53.
14. Oostrom KJ, Schouten A, Kruitwagen CLJ, et al. Behavioral problems in children with newly diagnosed idiopathic or cryptogenic epilepsy attending normal schools are in majority not persistent. Epilepsia 2003;44:97-106.
15. Austin JJ, Dunn DW, Caffrey HM, et al. Recurrent seizures and behavior problems in children with first recognized seizures: a prospective study. Epilepsia 2002;43:1564-73.
16. Oostrom KJ, Schouten A, Kruitwagen CL, et al. Dutch Study Group of Epilepsy in Childhood (DuSECH). Epilepsy-related ambiguity in rating the child behaviour checklist and the teacher's report form. Epileptic Disord 2001;3:39-45.
17. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-45.
18. Turner S, Nunn AJ, Fielding K, et al. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 1999;88:965-8.
19. Dalvi PS, Singh A, Trivedi HR, et al. Adverse drug reaction profile of oseltamivir in children. J Pharmacol Pharmacother 2011;2:100-3.
20. Martinbiancho JK, Carvalho PRA, de Andrade Trotta E, et al. Evidence of safety of chloral hydrate for prolonged sedation in PICU in a tertiary teaching hospital in southern Brazil. Eur J Clin Pharmacol 2009;65:1253-8.
21. Chalumeau M, Tonnelier S, d'Athis P, et al. Fluoroquinolone safety in pediatric patients: a prospective, multicenter, comparative cohort study in France. Pediatrics 2003;111:e714-e19.
22. Hamer HM, Dodel R, Strzelczyk A, et al. Prevalence, utilization, and costs of antiepileptic drugs for epilepsy in Germany-a nationwide population-based study in children and adults. J Neurol 2012;259:2376-84.
23. Van de Vrie-Hoekstra N, De Vries T, Van den Berg P, et al. Antiepileptic drug utilization in children from 1997-2005-a study from the Netherlands. Eur J Clin Pharmacol 2008;64:1013-20.
24. Kwong KL, Tsui KW, Wu SP, et al. Utilization of antiepileptic drugs in Hong Kong children. Pediatr Neurol 2012;46:281-6.
25. Dudley RW, Penney SJ, Buckley DJ. First-drug treatment failures in children newly diagnosed with epilepsy. Pediatr Neurol 2009;40:71-7.
26. Banu SH, Jahan M, Koli UK, et al. Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial. BMJ 2007;334:1207.
27. Ma MS, Ding YX, Ying W, et al. Effectiveness of the first antiepileptic drug in the treatment of pediatric epilepsy. Pediatr Neurol 2009;41:22-6.
28. Man CB, Kwan P, Baum L, et al. Association between HLA-B∗ 1502 allele and antiepileptic drug-induced cutaneous reactions in Han Chinese. Epilepsia 2007;48:1015-18.
29. Shorvon S, Chadwick D, Galbraith A, et al. One drug for epilepsy. Br Med J 1978;1:474-6.
30. Carpay HA, Arts WF, Geerts AT, et al. Epilepsy in childhood: an audit of clinical practice. Arch Neurol 1998;55:668-73.
31. Kanner AM, Balabanov AJ. The use of monotherapy in patients with epilepsy: an appraisal of the new antiepileptic drugs. Curr Neurol Neurosci Rep 2005;5:322-8.
32. Berg AT, Levy SR, Testa FM, et al. Remission of epilepsy after two drug failures in children: a prospective study. Ann Neurol 2009;65:510-19.
33. Thiesen S, Conroy EJ, Bellis JR, et al. Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children-a prospective observational cohort study of 6,601 admissions. BMC Med 2013;11:237.
34. 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.
35. St. Louis EK. Truly "rational" polytherapy: maximizing efficacy and minimizing drug interactions, drug load, and adverse effects. Curr Neuropharmacol 2009;7:96-105.
36. Li L, Russo M, O'Donoghur M, et al. Allergic skin rash with lamotrigine and concomitant valproate therapy. Arq Neuropsiquiatr 1996;54:47-9.
37. Anderson GD, Yau MK, Gidal BE, et al. Bidirectional interaction of valproate and lamotrigine in healthy subjects. Clin Pharmacol Ther 1996;60:145-56.
38. Bansal D, Azad C, Kaur M, et al. Adverse effects of antiepileptic drugs in North Indian pediatric outpatients. Clin Neuropharmacol 2013;36:107-13.
39. Carpay JA, Vermeulen J, Stroink H, et al. Parent-reported subjective complaints in children using antiepileptic drugs: what do they mean? Epilepsy Behav 2002;3:322-9.
40. Lucas L, Telechea H, Speranza N, et al. Pharmacovigilance incorporation to clinical practice for hospitalized children ongoing antiepileptic treatment. Drug Saf 2008;31:885.