Safety and tolerability of fexofenadine for the treatment of allergic rhinitis in children 2 to 5 years old.
BACKGROUND
The safety of fexofenadine has been examined extensively in adults and school-age children. However, the safety of fexofenadine in children younger than 6 years has not been reported to date.


OBJECTIVE
To compare the safety and tolerability of twice-daily fexofenadine hydrochloride, 30 mg, and placebo in preschool children aged 2 to 5 years with allergic rhinitis.


METHODS
This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study, conducted between February 29, 2000, and June 14, 2001. Participants were randomized to either fexofenadine hydrochloride, 30 mg, or placebo twice daily for a 2-week period. To facilitate dosing, capsule content was mixed with applesauce (approximately 10 mL). Safety assessments depended on date of entry into the study because of an amendment to the protocol. Before the amendment, assessments included physical examination, vital signs reporting (oral temperature, heart rate, and respiratory rate), and adverse event (AE) reporting. After the amendment, safety assessments included laboratory testing (blood chemistry and hematology profiles), physical examination, 12-lead electrocardiography, and vital signs (oral temperature, blood pressure, heart rate, and respiratory rate) and AE reporting.


RESULTS
Treatment-emergent AEs were observed in 116 of 231 participants receiving placebo and 111 of 222 receiving fexofenadine. These AEs were possibly related to study medication in 19 (8.2%) and 21 (9.5%) of the participants receiving placebo and fexofenadine, respectively, and most frequently involved the digestive system. No clinically relevant differences in laboratory measures, vital signs, and physical examinations were observed.


CONCLUSIONS
The findings show that fexofenadine hydrochloride, 30 mg, is well tolerated and has a good safety profile in children aged 2 to 5 years with allergic rhinitis.
Milgrom
Henry
H
Department of Pediatrics, University of Colorado Health Sciences Center, National Jewish Medical and Research Center, Denver 80206, USA. milgromh@njc.org
Kittner
Barbara
B
Lanier
Robert
R
Hampel
Frank C
FC
D000367:Age Factors; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001831:Body Temperature / Q000187:drug effects; D002675:Child, Preschool; D003371:Cough / Q000139:chemically induced; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007223:Infant; D008297:Male; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D016593:Terfenadine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D018926:Anti-Allergic Agents; D016593:Terfenadine; C093230:fexofenadine