Safety of cetirizine in infants 6 to 11 months of age: a randomized, double-blind, placebo-controlled study.
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.
Simons
F Estelle R
FE
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.
Silas
Peter
P
Portnoy
Jay M
JM
Catuogno
Joseph
J
Chapman
Douglass
D
Olufade
Abayomi O
AO
Pharmd
D017332:Cetirizine / Q000009:adverse effects*; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects*; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis / Q000188:drug therapy; D007223:Infant; D008297:Male
D039563:Histamine H1 Antagonists, Non-Sedating; D017332:Cetirizine