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No Safety Concerns when Fexofenadine Used in Children with Rhinitis: Presented at EAACI
By Jill Stein
PARIS, FRANCE -- June 11, 2003 -- Fexofenadine hydrochloride is safe and well tolerated when give at a twice-daily dose of 30 mg for treatment of allergic rhinitis in young children, according to data presented here on June 10th at the 22nd Congress of the European Academy of Allergology and Clinical Immunology.
Fexofenadine is a non-sedating, selective H1 receptor antagonist that is indicated in several countries for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children 6 to 11 years of age.
Dr. Robert Lanier, from North Texas Institute for Clinical Trials, in Fort Worth, presented results in 453 children aged 2 to 5 years with allergic rhinitis who were randomised to 2 weeks of treatment with fexofenadine 30 mg or placebo twice daily. Since children aged 2 to 5 cannot take oral tablets, treatment was administered orally after mixing the powder with applesauce.
About 60% of patients in both treatment groups reported the use of concomitant medications, most commonly analgesics and anti-asthmatic agents.
There were no unusual or unexpected treatment-related side effects with fexofenadine, the researchers reported. Treatment-related adverse events occurred in 50.2% of the fexofenadine group and 50.2% of the placebo group.
The body systems/organ classes in which the greatest number of children from both treatment groups experienced treatment-related adverse events were the respiratory system, body as a whole, and digestive system. The most common adverse events were upper respiratory infection, fever, infection, and vomiting.
There were no meaningful differences in the frequency of treatment related adverse events by body system observed for fexofenadine and placebo in any of the age groups.
The investigator judged that most of the adverse events reported were not related to the study medication. Treatment- related adverse events considered to be possible related to the study medication were reported in 9.5% of the fexofenadine group and 8.2% of the placebo group.
There were no clinically relevant changes from baseline to study end between the two treatment groups with respect to clinical laboratory values, vital signs, electrocardiogram findings, and physical examination results.
"The results support the findings of prior studies in adults and children aged 6 to 11 years and reinforce the safety of fexofenadine in these populations," Dr. Lanier said.
The study was sponsored by Aventis, of Bridgewater, New Jersey.
[Study title: Fexofenadine Has A Similar Safety And Tolerability Profile to Placebo In Children Aged 2-5 Years. Abstract 238]
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