Safety of fexofenadine in children treated for seasonal allergic rhinitis

• Published in: Annals of allergy, asthma, & immunology Vol. 87; no. 1; p. 22
• Main Authors: Graft, D F, Bernstein, D I, Goldsobel, A, Meltzer, E O, Portnoy, J, Long, J
• Format: Journal Article
• Language: English
• Published: United States 01-07-2001
• Subjects: Asthma - chemically induced; Child; Double-Blind Method; Humans; Rhinitis, Allergic, Seasonal - drug therapy; Terfenadine - adverse effects; Terfenadine - analogs & derivatives; Terfenadine - pharmacokinetics; Terfenadine - therapeutic use; Therapeutic Equivalency
• ISSN: 1081-1206
• DOI: 10.1016/S1081-1206(10)62317-4

The incidence of allergic rhinitis in children is increasing.
To evaluate the safety of fexofenadine HCI in children ages 6 through 11 years for treatment of seasonal allergic rhinitis.
Two large, double-blind, randomized, placebo-controlled, parallel studies with identical protocols included patients with a positive skin test to fall allergen(s) and allergic rhinitis symptoms. Patients were randomized to receive fexofenadine 15, 30, or 60 mg or placebo twice daily for 2 weeks after a 1-week placebo lead-in. Safety was evaluated through adverse event reporting, electrocardiograms, and pre- and posttreatment laboratory panels and physical examinations.
A total of 875 patients from both studies were eligible for safety analyses. Ten patients (5 on placebo, 5 on fexofenadine) discontinued because of an adverse event; no event that resulted in discontinuation was judged to be caused by study medication. Incidence of adverse events was similar in active and placebo groups, and did not increase with increasing fexofenadine dose: 36.2% (83 of 229) in the placebo group versus 35.3% (79 of 224), 36.8% (77 of 209), and 34.7% (74 of 213) in the 15, 30, and 60 mg twice-daily fexofenadine groups, respectively. Headache was the most commonly reported adverse event (6.6%, 8.0%, 7.2%, and 9.4% in the placebo, 15, 30, 60 mg twice-daily fexofenadine groups, respectively). Clinical, vital sign, electrocardiogram, and laboratory measures were similar in active and placebo groups. There was no statistically significant mean change from baseline in any electrocardiogram parameter after fexofenadine treatment.
Fexofenadine, 15, 30, and 60 mg twice daily, was safe and well tolerated in this large pediatric patient population.