Evolution of paediatric off-label use after new significant medicines become available for adults: A study on triptans in Finnish children 1994-2007

British Journal of Clinical Pharmacology

Volumn 71, Issue 6, 2011, Pages 929-935

  Lindkvist, Johanna ^a   Airaksinen, Marja ^a   Kaukonen, Ann Marie ^b   Klaukka, Timo ^b   Hoppu, Kalle ^b,c  

^a Divisions of Social Pharmacy   (Finland)

^b UNIVERSITY OF HELSINKI   (Finland)

^c HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

Author keywords

Labelling; Off label drug use; Paediatric; Triptan

Indexed keywords

ALMOTRIPTAN; ELETRIPTAN; FROVATRIPTAN; GLYCERYL TRINITRATE; NARATRIPTAN; RIZATRIPTAN; SUMATRIPTAN; SUMATRIPTAN SUCCINATE; ZOLMITRIPTAN;

ADOLESCENT; ARTICLE; CHILD; CONTROLLED STUDY; DRUG MARKETING; FEMALE; FINLAND; HUMAN; MAJOR CLINICAL STUDY; MALE; MIGRAINE; OFF LABEL DRUG USE; PRESCHOOL CHILD; PRESCRIPTION; PRIORITY JOURNAL; SCHOOL CHILD;

ADOLESCENT; ADULT; AGE FACTORS; CHILD; DRUG APPROVAL; FEMALE; FINLAND; HUMANS; MALE; MIGRAINE DISORDERS; OFF-LABEL USE; OXAZOLIDINONES; SEROTONIN 5-HT1 RECEPTOR AGONISTS; SUMATRIPTAN; TIME FACTORS; TRIAZOLES; TRYPTAMINES; YOUNG ADULT;

EID: 79955835951     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03881.x     Document Type: Article

References (35)

1. Impicciatore P, Choonara I. Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use. Br J Clin Pharmacol 1999; 48: 15-8.
2. ICH Guidance E11. Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99). Available at (last accessed 30 December 2010).
3. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, de Hoog M, van den Anker J. Survey of unlicensed and off-label drug use in paediatric wards in European countries. BMJ 2000; 320: 79-82.
4. McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off-label prescribing of drugs in general practice. Arch Dis Child 2000; 83: 498-501.
5. Schirm E, Tobi H, de Jong-van den Berg L. Unlicensed and off-label drug use by children in the community: cross sectional study. BMJ 2002; 324: 1312-3.
6. Stafford RS. Regulating off-label drug use - rethinking the role of the FDA. N Engl J Med 2008; 358: 1427-9.
7. Schirm E, Tobi H, de Jong-van den Berg L. Risk factors for unlicensed and off-label drug use in children outside the hospital. Pediatrics 2003; 111: 291-5.
8. Turner S, Nunn A, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drug use in paediatric wards: prospective study. Acta Paediatr 1999; 88: 965-8.
9. Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf 2006; 5: 703-18.
10. Sillanpää M. Changes in the prevalence of migraine and other headaches during the first seven school years. Headache 1983; 23: 15-9.
11. Abu-Arefeh I, Russell G. Prevalence of headache and migraine in schoolchildren. BMJ 1994; 309: 765-9.
12. Järvelin J. Health care systems in transitions. European observatory on health care systems 2002; 4. Available at (last accessed 30 December 2010).
13. Ministry of Social Affairs and Health. Health Care in Finland. Helsinki, Finland 2004. Available at (last accessed 30 December 2010).
14. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index. Available at (last accessed 30 December 2010).
15. National Agency for Medicines. Information on medicinal products intended for human or veterinary use in Finland. Available at (last accessed 30 December 2010).
16. Bille B. Migraine in school children. Acta Paediatr Scand 1962; 136: (51 Suppl.): 1-151.
17. European Parliament and Council of the European Union. Directive 2001/83/EC on the Community code relating to medicinal products for human use. Available at (last accessed 30 December 2010).
18. Evers S. Drug treatment of migraine in children: a comparative review. Paediatr Drugs 1999; 1: 7-18.
19. Evers S, Pothmann R, Überall M, Naumann E, Gerber WD. Therapie idiopathischer Kopfschmerzen im Kindesalter - Empfehlungen der Deutschen Migräne- und Kopfschmerzgesellschaft (DMKG). Schmerz 2002; 16: 48-56.
20. Major P, Grubisa H, Thie N. Triptans for treatment of acute pediatric migraine: a systematic literature review. Pediatr Neurol 2003; 29: 425-9.
21. Géraud G, Lantéri-Minet M, Lucas C, Valade D. French Society for the Study of Migraine Headache (SFEMC). French guidelines for the diagnosis and management of migraine in adults and children. Clin Ther 2004; 26: 1305-18.
22. Lewis D, Ashwal S, Hershey A, Hirtz D, Yonker M, Silberstein S. Report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society. Practice parameter: pharmacological treatment of migraine headache in children and adolescents. Neurology 2004; 63: 2215-24.
23. Damen L, Bruijn J, Verhagen A, Berger M, Passchier J, Koes B. Symptomatic treatment of migraine in children: a systematic review of medication trials. Pediatrics 2005; 116: 295-302.
24. Lewis D, Winner P. The pharmacological treatment options for pediatric migraine: an evidence-based appraisal. NeuroRx 2006; 3: 181-91.
25. Pakalnis A. Current therapies in childhood and adolescent migraine. J Child Neurol 2007; 22: 1288-92.
26. Linder SL. Subcutaneous sumatriptan in the clinical setting: the first 50 consecutive patients with acute migraine in the pediatric neurology office practice. Headache 1996; 36: 419-22.
27. Ueberall MA, Wenzel D. Intranasal sumatriptan for the acute treatment of migraine in children. Neurology 1999; 52: 1507-10.
28. Linder SL, Dowson AJ. Zolmitriptan provides effective migraine relief in adolescents. Int J Clin Pract 2000; 54: 466-9.
29. Winner P, Rothner AD, Saper J, Nett R, Asgharnejad M, Laurenza A, Austin R, Peykamian M. A randomized, double-blind, placebo-controlled study of sumatriptan nasal spray in the treatment of acute migraine in adolescents. Pediatrics 2000; 106: 989-97.
30. Ahonen K, Hämäläinen ML, Rantala H, Hoppu K. Nasal sumatriptan is effective in treatment of migraine attacks in children: a randomized trial. Neurology 2004; 62: 883-7.
31. Damen L, Bruijn JK, Verhagen AP, Berger MY, Passchier J, Koes BW. Symptomatic treatment of migraine in children: a systematic review of medication trials. Pediatrics 2005; 16: 295-302.
32. Hämäläinen ML, Hoppu K, Valkeila E, Santavuori PR. Ibuprofen or acetaminophen for the acute treatment of migraine in children: a randomized placebo-controlled double-blind crossover study. Neurology 1997; 48: 103-7.
33. EMA. Assessment of the Paediatric Needs - Migraine. London 2006. Available at (last accessed 30 December 2010).
34. European Parliament and Council of the European Union. European Paediatric Regulation. Regulation (EC) No 1901/2006. Available at (last accessed 30 December 2010).
35. National Agency for Medicines and the Social Insurance Institution. The Finnish Statistics on Medicines. Available at (last accessed 30 December 2010).