ORIGINAL ARTICLES
Safety of fexofenadine in children treated for seasonal allergic rhinitis

https://doi.org/10.1016/S1081-1206(10)62317-4Get rights and content

Background

The incidence of allergic rhinitis in children is increasing.

Objective

To evaluate the safety of fexofenadine HCl in children ages 6 through 11 years for treatment of seasonal allergic rhinitis.

Methods

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.

Results

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.

Conclusions

Fexofenadine, 15, 30, and 60 mg twice daily, was safe and well tolerated in this large pediatric patient population.

REFERENCES (20)

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Cited by (37)

  • Safety and tolerability of fexofenadine for the treatment of allergic rhinitis in children 2 to 5 years old

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    Second-generation antihistamines, such as fexofenadine, are associated with fewer adverse events (AEs) than first-generation antihistamines because of improved histamine1-receptor specificity and reduced capacity to cross the blood-brain barrier.16,17 The safety of fexofenadine has been examined extensively in adults18,19 and school-age children.20-22 However, to date, the safety of fexofenadine in children younger than 6 years has not been established.

  • Pediatric allergic rhinitis: Treatment

    2005, Immunology and Allergy Clinics of North America
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This research was supported by a grant from Aventis Pharmaceuticals Inc.

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