Safety of desloratadine syrup in children

BACKGROUND: Allergic rhinitis (AR) and acute urticaria are common childhood maladies. Typically, the firstline treatment options for both include non-sedating antihistamines. First-generation antihistamines, such as diphenhydramine and hydroxyzine, although useful, cause sedation. Desloratadine, an oral non-sedating antihistamine, has been shown in multiple studies to be safe and effective in relieving the symptoms of AR and chronic idiopathic urticaria (CIU) in adults and adolescents. OBJECTIVE AND METHODS: The current double-blind, placebo-controlled, parallel-group, single-center studies were undertaken to determine the safety and tolerability of desloratadine syrup in children aged 2 years-11 years with AR or CIU. Over 14 days, subjects aged 2 years-5 years were randomly assigned to receive once a day either 1.25 mg of desloratadine syrup (0.5 mg/mL) or matching placebo, and subjects aged 6 years-11 years were randomly assigned to receive once a day either 2.5 mg of desloratadine syrup or matching placebo. Safety evaluations included adverse event report collection, monitoring of vital signs, clinical laboratory measurements, and standard 12-lead electrocardiogram (ECG) measurements. RESULTS: In the study involving subjects aged 2 years-5 years (n = 111), the incidence of adverse events was 7/55 for the group treated with desloratadine and 6/56 for placebo. In the study involving subjects aged 6 years-11 years (n = 120), the incidence of adverse events was 1/60 for the group treated with desloratadine and 6/60 for placebo. No severe or serious adverse events occurred, and no clinically relevant changes were noted in median clinical laboratory test values or mean vital signs in either group. ECG results from both age groups demonstrated no significant changes (p = NS) in mean ventricular rate or PR, QRS, or QT. No subjects had a Fridericia QT(c) interval > 440 ms at day 8 or day 15. CONCLUSION: These studies demonstrate the safety of desloratadine syrup in children aged 2 years-11 years with AR or CIU.