| 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 |
Related Documents
:
|
10966894 - Assessment of vitamin b-12, folate, and vitamin b-6 status and relation to sulfur amino... 14756914 - Mental and psychomotor development in indonesian infants of mothers supplemented with v... 6768214 - Plasminogen levels in subjects with eosinophilia. 2171984 - Soybean lipoxygenase-1 is not a quinoprotein. 12548734 - Extended phenotype of pontocerebellar hypoplasia with infantile spinal muscular atrophy. 19397554 - Necrotizing enterocolitis following the use of intravenous immunoglobulin for haemolyti... |
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. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| 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
Previous Document: Pregnancy outcome after gestational exposure to loratadine or antihistamines: a prospective controll...
Next Document: Presence of atopy in first-degree relatives as a predictor of a female proband's depression: results...