Off-label prescribing for allergic diseases in pre-school children

Allergologia et Immunopathologia

Volumn 42, Issue 4, 2014, Pages 342-347

  Morais Almeida, M ^a   Cabral, A J ^a  

^a CUF Descobertas Hospital   (Portugal)

Author keywords

Asthma; Atopic eczema; Infant; Off label prescription; Pre school children; Rhinitis

Indexed keywords

ANTIHISTAMINIC AGENT; BUDESONIDE; CETIRIZINE; CORTICOSTEROID DERIVATIVE; DESLORATADINE; EBASTINE; FLUTICASONE; FLUTICASONE FUROATE; IMMUNOMODULATING AGENT; KETOTIFEN; LEUKOTRIENE RECEPTOR STIMULATING AGENT; LEVOCETIRIZINE; LORATADINE; MOMETASONE FUROATE; MONTELUKAST; PIMECROLIMUS; SALMETEROL; ANTIALLERGIC AGENT;

ADOLESCENT; ALLERGIC ASTHMA; ALLERGIC RHINITIS; ARTICLE; ATOPIC DERMATITIS; CHILD; CHILDHOOD DISEASE; CONSULTATION; CONTROLLED STUDY; FEMALE; HUMAN; IMMUNOLOGY; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; OFF LABEL DRUG USE; PRESCHOOL CHILD; PRESCRIPTION; CLINICAL PRACTICE; HYPERSENSITIVITY; INFANT; STATISTICS AND NUMERICAL DATA;

ANTI-ALLERGIC AGENTS; CHILD, PRESCHOOL; FEMALE; HUMANS; HYPERSENSITIVITY; INFANT; MALE; OFF-LABEL USE; PHYSICIAN'S PRACTICE PATTERNS;

EID: 84903818670     PISSN: 03010546     EISSN: 15781267     Source Type: Journal    
DOI: 10.1016/j.aller.2013.02.011     Document Type: Article

References (30)

1. Gazarian M., Kelly M., McPhee J.R., Graudins L.V., Ward R.L., Campbell T.J. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006, 185:544-548.
2. Burns J.P. Research in children. Crit Care Med 2003, 31(Suppl. 3):S131-S136.
3. Pandolfini C., Bonati M. A literature review on off-label drug use in children. Eur J Pediatr 2005, 164:552-558.
4. Choonara I., Conroy S. Unlicensed and off-label drug use in children: implications for safety. Drug Saf 2002, 25:1-5.
5. Ghaleb M.A., Barber N., Franklin B.D., Yeung V.W., Khaki Z.F., Wong I.C. Systematic review of medication errors in pediatric patients. Ann Pharmacother 2006, 40:1766-1776.
6. Collier J. Paediatric prescribing: using unlicensed drugs and medicines outside their licensed indications. Br J Clin Pharmacol 1999, 48:5-8.
7. Uses of drugs not described in the package insert (off-label uses). Pediatrics 2002, 110:181-183.
8. Bennett W.M. Off-label use of approved drugs: therapeutic opportunity and challenges. J Am Soc Nephrol 2004, 15:830-831.
9. t Jong G.W., Eland I.A., Sturkenboom M.C., van den Anker J.N., Strickerf B.H. Unlicensed and off-label prescription of respiratory drugs to children. Eur Respir J 2004, 23:310-313.
10. Sen E.F., Verhamme K.M., Neubert A., Hsia Y., Murray M., Felisi M., et al. Assessment of pediatric asthma drug use in three European countries; a TEDDY study. Eur J Pediatr 2011, 170:81-92.
11. Information about authorized drugs use; 2012. Available at: [accessed 20.06.12]. http://www.infarmed.pt/infomed/inicio.php.
12. Note for guidance on clinical investigation of medicinal products in children 1997, European Agency for the Evaluation of Medicinal Products HMEU, London.
13. Meadows M. Drug research and children. FDA Consum 2003, 37:12-17.
14. Steinbrook R. Testing medications in children. N Engl J Med 2002, 347:1462-1470.
15. ICH Guidance E11: Note for guidance on clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99); 2012 (June). Available from: [on-line]. http://www.ema.europa.eu/pdfs/human/ich/271199en.pdf.
16. Amending Regulation EC No. 1902/2006 on medicinal products for paediatric use; 2012 (June). Available from: [online]. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1902/reg_2006_1902_en.pdf.
17. Dunne J. The European Regulation on medicines for paediatric use. Paediatr Respir Rev 2007, 8:177-183.
18. Sammons H.M., Choonara I. What is happening to improve drug therapy in children. Paediatr Child Health 2007, 17:108-110.
19. Infarmed Utilização de medicamentos off-label 2010, Infarmed.
20. Riordan F.A. Use of unlabelled and off licence drugs in children. Use of unlicensed drugs may be recommended in guidelines. BMJ 2000, 320:1210.
21. McLay J.S., Tanaka M., Ekins-Daukes S., Helms P.J. A prospective questionnaire assessment of attitudes and experiences of off label prescribing among hospital based paediatricians. Arch Dis Child 2006, 91:584-587.
22. Informations about authorized drugs use obtained on U.S. Food and Drug Administration (FDA) site; 2012. FDA. Available online at: [accessed 20.06.12]. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
23. Simons F.E. Safety of levocetirizine treatment in young atopic children: an 18-month study. Pediatr Allergy Immunol 2007, 18:535-542.
24. Wuthrich B., Schmid-Grendelmeier P. The atopic eczema/dermatitis syndrome. Epidemiology, natural course, and immunology of the IgE-associated (extrinsic) and the nonallergic (intrinsic) AEDS. J Investig Allergol Clin Immunol 2003, 13:1-5.
25. Informations about authorized drugs use obtained on European Medicines Agency (EMA) site; 2012. EMA. Available online at: [assessed 26.06.12]. http://www.ema.europa.eu/ema/index.jsp%3Fcurl=/pages/medicines/landing/epar_search.jsp%26mid=WC0b01ac058001d124.
26. Munzenberger P.J., Montejo J.M. Safety of topical calcineurin inhibitors for the treatment of atopic dermatitis. Pharmacotherapy 2007, 27:1020-1028.
27. Patel R.R., Vander Straten M.R., Korman N.J. The safety and efficacy of tacrolimus therapy in patients younger than 2 years with atopic dermatitis. Arch Dermatol 2003, 139:1184-1186.
28. Papp K.A., Breuer K., Meurer M., Ortonne J.P., Potter P.C., de Prost Y., et al. Long-term treatment of atopic dermatitis with pimecrolimus cream 1% in infants does not interfere with the development of protective antibodies after vaccination. J Am Acad Dermatol 2005, 52:247-253.
29. List of paediatrics needs (as established by the Paediatric Working Party); 2012 (June). Available from: http://www.emea.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004058.pdf.
30. Blatman K.H., Ditto A.M. Eosinophilic esophagitis. Allergy Asthma Proc 2012, 33(Suppl. 1):88-90.