Document Detail


Safety of cetirizine in infants 6 to 11 months of age: a randomized, double-blind, placebo-controlled study.
MedLine Citation:
PMID:  12789224     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: H(1)-antihistamines are widely used for symptom relief in allergic disorders in infants and children; however, there are few prospective, randomized, double-blind, controlled studies of these medications in young children, and to date, no such studies have been conducted in infants. OBJECTIVE: This prospective, randomized, parallel-group, double-blind, placebo-controlled study was designed to evaluate the safety of the H(1)-antihistamine cetirizine, particularly with regard to central nervous system and cardiac effects, in infants age 6 to 11 months, inclusive. METHODS: Infants who met the entry criteria for age and had a history of treatment with an H(1)-antihistamine for an allergic or other disorder were randomized to receive 0.25 mg/kg cetirizine orally or matching placebo twice daily orally for 1 week. RESULTS: The mean daily dose in cetirizine-treated infants was 4.5 +/- 0.7 mg (SD). No differences in all-cause or treatment-related adverse events were observed between the cetirizine- and placebo-treated groups. A trend was observed toward fewer adverse events and sleep-related disturbances in the cetirizine group compared with the placebo group. No prolongation in the linear corrected QT interval was observed in cetirizine-treated infants compared with either baseline values or with values in placebo-treated infants. CONCLUSIONS: We have documented the safety of cetirizine in this short-term investigation, the first randomized, double-blind, placebo-controlled study of any H(1)-antihistamine in infants. Additional prospective, randomized, double-blind, placebo-controlled, long-term studies of cetirizine and other H(1)-antihistamines are needed in this population.
Authors:
F Estelle R Simons; Peter Silas; Jay M Portnoy; Joseph Catuogno; Douglass Chapman; Abayomi O Olufade; Pharmd
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of allergy and clinical immunology     Volume:  111     ISSN:  0091-6749     ISO Abbreviation:  J. Allergy Clin. Immunol.     Publication Date:  2003 Jun 
Date Detail:
Created Date:  2003-06-05     Completed Date:  2003-07-03     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  1275002     Medline TA:  J Allergy Clin Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1244-8     Citation Subset:  AIM; IM    
Affiliation:
Section of Allergy and Clinical Immunology, Department of Pediatrics and Child Health, Faculty of Medicine, The University of Manitoba, 820 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1R9.
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MeSH Terms
Descriptor/Qualifier:
Cetirizine / adverse effects*
Double-Blind Method
Electrocardiography
Female
Hemodynamics / drug effects
Histamine H1 Antagonists, Non-Sedating / adverse effects*
Humans
Hypersensitivity / diagnosis,  drug therapy
Infant
Male
Chemical
Reg. No./Substance:
0/Histamine H1 Antagonists, Non-Sedating; 83881-51-0/Cetirizine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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