Prioritizing children's medicines for research: A pharmacoepidemiological study of antiepileptic drugs

British Journal of Clinical Pharmacology

Volumn 63, Issue 6, 2007, Pages 689-697

  Ackers, Ruth ^a,b,c   Murray, MacEy L ^a,b,c   Besag, Frank M C ^c   Wong, Ian C K ^a,b,c  

^a UNIVERSITY OF LONDON   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c Bedfordshire and Luton Partnership NHS Trust ^*  (United Kingdom)

Author keywords

Anticonvulsants antiepileptic drugs; Child adolescent infant; Drug utilization; Epilepsy; Pharmacoepidemiology

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; ETHOSUXIMIDE; ETIRACETAM; GABAPENTIN; LAMOTRIGINE; OXCARBAZEPINE; PHENOBARBITAL; PHENYTOIN; PREGABALIN; TIAGABINE; TOPIRAMATE; VALPROIC ACID; VIGABATRIN; ZONISAMIDE;

ADJUVANT THERAPY; ADOLESCENT; ADULT; AGE; ARTICLE; CHILD; CONFIDENCE INTERVAL; DRUG UTILIZATION; EPILEPSY; FEMALE; HUMAN; INCIDENCE; INFANT; LICENSING; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; PHARMACOEPIDEMIOLOGY; PRESCRIPTION; PREVALENCE; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; UNITED KINGDOM;

ADOLESCENT; ANTICONVULSANTS; CHILD; CHILD, PRESCHOOL; DATABASES; DECISION MAKING; DRUG UTILIZATION; EPILEPSY; GREAT BRITAIN; HUMANS; INFANT; INFANT, NEWBORN; PHYSICIAN'S PRACTICE PATTERNS; PRESCRIPTIONS, DRUG; PRIMARY HEALTH CARE;

EID: 34248589701     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2006.02842.x     Document Type: Article

References (37)

1. US Food and Drug Administration. The Paediatric Research Equity Act. Public Law 108-155. Available at http://www.fda.gov/cder/pediatric/S-650-PREA. pdf Last accessed 22 May 2006.
2. US Department of Health and Human Services, National Institutes of Health. Available at http://www.nih.gov/ Last accessed 22 May 2006.
3. European Commission. Better Medicines for Children: Proposed Regulatory Actions on Paediatric Medicinal Products. Available at http://pharmacos.eudra. org/F2/pharmacos/docs/Doc2002/feb/cd_pediatrics_en.pdf Last accessed 17 May 2006.
4. The European Agency for the Evaluation of Medicinal Products and Human Medicines Evaluation Unit. Report of the Experts Round Table on the Difficulties Related to the Use of New Medicinal Products in Children Held on 18 December 1997. Available at http://www.emea.eu.int/pdfs/human/regaffair/2716498en.pdf Last accessed 17 May 2006.
5. European Medicines Agency. Available at http://www.emea.eu.int/htms/ human/peg/pegassessment.htm# Last accessed 17 May 2006.
6. European Medicines Agency and Pre-authorisation Evaluation of Medicines for Human Use. Assessment of the Paediatric Needs in Epilepsy. Available at http://www.emea.eu.int/pdfs/human/peg/40591105en.pdf Last accessed 17 May 2006.
7. Task-force in Europe for Drug Development for the Young. Available at http://www.teddyoung.org/index.php Last accessed 22 May 2006.
8. National Institute for Clinical Excellence. Newer Drugs for Epilepsy in Children. Available at http://www.nice.org.uk/download.aspx?o=ta079guidance Last accessed 25 April 2006.
9. Knoester PD, Belitser SV, Deckers CLP, Keyser A, Renier WO, Egberts ACG, Hekster YA. Diffusion of the new antiepileptic drug lamotrigine in Dutch clinical practice. Eur J Clin Pharmacol 2004 60 : 751 8.
10. The General Practice Research Database. Available at http://www.gprd.com/ home/ Last accessed 25 April 2006.
11. Wong ICK, Murray ML. The potential of UK clinical databases in enhancing paediatric medication research. Br J Clin Pharmacol 2005 59 : 750 5.
12. Hollowell J. The General Practice Research Database: quality of morbidity data. Popul Trends 1997 87 : 36 40.
13. Wood L, Martinez C. The General Practice Research Database: role in pharmacovigilance. Drug Saf 2004 27 : 871 81.
14. The European Agency for the Evaluation of Medicinal Products and Evaluation of Medicines for Human Use. Clinical Investigation of Medicinal Products in the Paediatric Population. Available at http://www.emea.eu.int/pdfs/ human/ich/271199EN.pdf Last accessed 25 April 2006.
15. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000 342 : 314 9.
16. Camfield C, Camfield P, Gordon K, Smith B, Dooley J. Outcome of childhood epilepsy: a population-based study with a simple predictive scoring system for those treated with medication. J Pediatr 1993 122 : 861 8.
17. Eke T, Talbot JF, Lawden MC. Severe persistent visual field constriction associated with vigabatrin. BMJ 1997 314 : 180 1.
18. Medicines and Healthcare products Regulatory Agency. Vigabatrin (Sabril) and Visual Field Defects. Current Problems 25. Available at http://www.mhra.gov. uk/home/groups/pl-p/documents/publication/con007464.htm Last accessed 25 April 2006.
19. Brodie MJ, Richens A, Yuen AWC. Double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy. Lancet 1995 345 : 476 9.
20. Beghi E. Efficacy and tolerability of the new antiepileptic drugs: comparison of two recent guidelines. Lancet Neurol 2004 3 : 618 21.
21. Steiner TJ, Dellaportas CI, Findley LJ, Gross M, Gibberd FB, Perkin GD, Park DM, Abbott R. Lamotrigine monotherapy in newly diagnosed untreated epilepsy: a double-blind comparison with phenytoin. Epilepsia 1999 40 : 601 7.
22. Patsalos PN, Perucca E. Clinically important drug interactions in epilepsy: general features and interactions between antiepileptic drugs. Lancet Neurol 2003 2 : 347 56.
23. Perucca E. An introduction to antiepileptic drugs. Epilepsia 2005 46 (Suppl. 4 31 7.
24. Crawford P. Interactions between antiepileptic drugs and hormonal contraception. CNS Drugs 2002 16 : 263 72.
25. Sidhu J, Job S, Singh S, Philipson R. The pharmacokinetic and pharmacodynamic consequences of the co-administration of lamotrigine and a combined oral contraceptive in healthy female subjects. Br J Clin Pharmacol 2006 61 : 191 9.
26. Sabers A, Buchholt JM, Uldall P, Hansen EL. Lamotrigine plasma levels reduced by oral contraceptives. Epilepsy Res 2001 47 : 151 4.
27. Sabers A, Ohman I, Christensen J, Tomson T. Oral contraceptives reduce lamotrigine plasma levels. Neurology 2003 61 : 570 1.
28. Morrow J, Russell A, Guthrie E, Parsons L, Robertson I, Waddell R, Irwin B, McGivern RC, Morrison PJ, Craig J. Malformation risks of antiepileptic drugs in pregnancy: a prospective study from the UK Epilepsy and Pregnancy Register. J Neurol Neurosurg Psychiatry 2006 77 : 193 8.
29. Elterman RD, Shields WD, Mansfield KA, Nakagawa J, US Infantile Spasms Vigabatrin Study Group. Randomized trial of vigabatrin in patients with infantile spasms. Neurology 2001 57 : 1416 21.
30. Appleton RE. Drug treatment of paediatric epilepsy. In : Epilepsy 2005 from Neuron to NICE - a Practical Guide, Sander JW, Walker MC, Smalls JE. International League Against Epilepsy 2005 : 313.
31. Wong ICK, Lhatoo SD. Adverse reactions to new anticonvulsant drugs. Drug Safety 2000 23 : 35 56.
32. Hirsch LJ, Weintraub DB, Buchsbaum R, Spencer HT, Straka T, Hager M, Resor SR Jr. Predictors of lamotrigine-associated rash. Epilepsia 2006 47 : 318 22.
33. Committee on Safety of Medicines and the Medicines and Healthcare Regulatory Agency. Lamotrigine (Lamictal): Increased risk of serious skin reactions in children. Current Problems Pharmacovigilance 1997 23 : 8.
34. Committee on Safety of Medicines and the Medicines and Healthcare Regulatory Agency. Lamotrigine (Lamictal): rare blood dyscrasias. Current Problems Pharmacovigilance 2000 26 : 4.
35. Committee on Safety of Medicines and the Medicines and Healthcare Regulatory Agency. Topiramate (Topamax): acute myopia and raised intraocular pressure. Current Problems Pharmacovigilance 2002 28 : 4.
36. Bekkelund SI, Lilleng H, Tonseth S. Gabapentin may cause reversible visual field constriction. BMJ 2006 332 : 1193.
37. Electronic Medicines Compendium. Available at http://emc.medicines.org. uk/ Last accessed 25 April 2006.