Prospective, long-term safety evaluation of the H1-receptor antagonist cetirizine in very young children with atopic dermatitis

Journal of Allergy and Clinical Immunology

Volumn 104, Issue 2 I, 1999, Pages 433-440

  Simons, F Estelle R ^a,b  

^a UNIVERSITY OF MANITOBA   (Canada)

^b CHILDREN S HOSPITAL RESEARCH INSTITUTE OF MANITOBA   (Canada)

Author keywords

Allergy; Antihistamine; Atopic dermatitis; Child; H1 receptor antagonist; Infant; Long term safety; QTc interval; Randomized trial; Somnolence

Indexed keywords

CETIRIZINE; HISTAMINE H1 RECEPTOR ANTAGONIST;

ARTICLE; ATAXIA; ATOPIC DERMATITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG EFFICACY; DRUG RECEPTOR BINDING; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; HUMAN CELL; HUMAN TISSUE; INFANT; INSOMNIA; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; NEUROTOXICITY; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 0032849162     PISSN: 00916749     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0091-6749(99)70389-1     Document Type: Article

References (37)

1. 1-receptor antagonists in allergic disease. New York (NY): Marcel Dekker, Inc; 1996. p. 329-56.
2. Kogan MD, Pappas G, Yu SM, Kotelchuck M. Over-the-counter medication use among US preschool-age children. JAMA 1994;272:1025-30.
3. Smith MBH, Feldman W. Over-the-counter cold medications: a critical review of clinical trials between 1950 and 1991. JAMA 1993;269:2258-63.
4. Oranje AP, Stalder JF, Taibe A, Tasset C, deLongueville M, for the ETAC Study Group. Scoring of atopic dermatitis by SCORAD using a training atlas by investigators from different disciplines. Pediatr Allergy Immunol 1997;8:28-34.
5. Warner JO, for the ETAC Study Group. Determinants of total and specific IgE in infants with atopic dermatitis. Pediatr Allergy Immunol 1997;8:177-84.
6. Wahn U, et al for the ETAC Study Group. Allergic factors associated with the development of asthma and the influence of cetirizine in a double-blind, randomized, placebo-controlled trial: first results of ETAC. Pediatr Allergy Immunol 1998;9:116-24.
7. de Longueville M, Deruyter B. RR, QT, and QTc in 799 infants aged 1-2 years. J Allergy Clin Immunol 1998;101:S198.
8. Richman N, Graham PJ. A behavior screening questionnaire for use with three year old children: preliminary findings. J Child Psychol Psychiatry 1971;12:5-33.
9. McCarthy D. McCarthy scales of children's abilities, manual. New York: The Psychological Corporation; 1972.
10. Ridout SM, Tariq SM. Cetirizine overdose in a young child [letter]. J Allergy Clin Immunol 1997;99:860-1.
11. Wyngaarden JB, Seevers MH. The toxic effects of antihistaminic drugs. JAMA 1951;145:277-82.
12. Magera BE, Betlach CJ, Sweatt AP, Derrick CW Jr. Hydroxyzine intoxication in a 13-month-old child. Pediatrics 1981;67:280-3.
13. Watemberg NM, Roth KS, Alehan FK, Epstein CE. Central anticholinergic syndrome on therapeutic doses of cyproheptadine. Pediatrics 1999;103:158-60.
14. Dollberg S, Hurvitz H, Kerem E, Navon P, Branski D. Hallucinations and hyperthermia after promethazine ingestion. Acta Paediatr Scand 1989;78:131-2.
15. Goetz CM, Lopez G, Dean BS, Krenzelok EP. Accidental childhood death from diphenhydramine overdosage. Am J Emerg Med 1990;8:321-2.
16. 1 antagonist, confirmed by the use of d-chlorpheniramine with monitoring electroencephalography. Meth Find Exp Clin Pharmacol 1993;15:183-8.
17. Le Blaye I, Donatini B, Hall M, Krupp P Acute ketotifen overdosage: a review of present clinical experience. Drug Safety 1992;7:387-92.
18. Hickson GB, Altemeier WA, Clayton EW Should promethazine in liquid form be available without prescription? Pediatrics 1990;86:221-5.
19. Reilly JF Jr, Weisse ME. Topically induced diphenhydramine toxicity. J Emerg Med 1990;8:59-61.
20. Hoppu K, Tikanoja T, Tapanainen P, Remes M, Saarenpää-Heikkilä O, Kouvalainen K. Accidental astemizole overdose in young children. Lancet 1991;338:538-40.
21. Tobin JR, Doyle TP, Ackerman AD, Brenner JI. Astemizole-induced cardiac conduction disturbances in a child. JAMA 1991;266:2737-40.
22. Wiley JF II, Gelber ML, Henretig FM, Wiley CC, Sandhu S, Loiselle J. Cardiotoxic effects of astemizole overdose in children. J Pediatr 1992;120:799-802.
23. Dahl RE, Bernhisel-Broadbent J, Scanlon-Holdford S, Sampson HA, Lupo M. Sleep disturbances in children with atopic dermatitis. Arch Pediatr Adolesc Med 1995;149:856-60.
24. Spicak V, Dab I, Hulhoven R, Desager J-P, Klanova M, de Longueville M, et al. Pharmacokinetics and pharmacodynamics of cetirizine in infants and toddlers. Clin Pharmacol Ther 1997;61:325-30.
25. 1-receptor antagonist cetirizine in very young children. Clin Pharmacol Ther 1993;53:431-5.
26. Pariente-Khayat A, Rey E, Dubois MC, Vauzelle-Kervroedan F, Pons G, D'Athis P, et al. Pharmacokinetics of cetirizine in 2- to 6-year-old children. Int J Clin Pharmacol Ther 1995;33:340-4.
27. Watson WTA, Simons KJ, Chen XY, Simons FER. Cetirizine: a pharmacokinetic and pharmacodynamic evaluation in children with seasonal allergic rhinitis. J Allergy Clin Immunol 1989;84:457-64.
28. 1-receptor antagonists in skin and serum. J Allergy Clin Immunol 1995;95:759-64.
29. 1-receptor antagonist drugs. N Engl J Med 1994;330:1663-70.
30. Groswasser J, Brusquet Y, Cornus A, Saké J-K, de Longueville M, Kahn A. Effects of cetirizine in night polygraphic recording in infants [abstract]. Pediatr Allergy Immunol 1995;6(8 suppl):96.
31. Baelde Y, Dupont P. Cetirizine in children with chronic allergic rhinitis: a multicentre double-blind study of two doses of cetirizine and placebo. Drug Invest 1992;4:466-72.
32. Allegra L, Paupe J, Wieseman HG, Baelde Y. Cetirizine for seasonal allergic rhinitis in children aged 2-6 years: a double-blind comparison with placebo. Pediatr Allergy Immunol 1993;4:157-61.
33. Masi M, Candiani R, van de Venne H. A placebo-controlled trial of cetirizine in seasonal allergic rhino-conjunctivitis in children aged 6 to 12 years. Pediatr Allergy Immunol 1993;4:47-52.
34. Jobst S, van den Wijngaart W, Schubert A, van de Venne H. Assessment of the efficacy and safety of three dose levels of cetirizine given once daily in children with perennial allergic rhinitis. Allergy 1994;49:598-604.
35. Pearlman DS, Lumry WR, Winder JA, Noonan MJ. Once-daily cetirizine effective in the treatment of seasonal allergic rhinitis in children aged 6 to 11 years: a randomized, double-blind, placebo-controlled study. Clin Pediatr 1997;36:209-15.
36. La Rosa M, Ranno C, Musarra I, Guglielmo F, Corrias A, Bellanti JA. Double-blind study of cetirizine in atopic eczema in children. Ann Allergy 1994;73:117-22.
37. Winder J, Noonan MJ. A randomized, placebo-controlled study to evaluate the electrocardiographic effects of cetirizine in children aged 6 to 11 [abstract]. J Allergy Clin Immunol 1996;97:342.