Safety and tolerability of levocetirizine dihydrochloride in infants and children with allergic rhinitis or chronic urticaria

Abstract

Allergic rhinitis (AR) and chronic idiopathic urticaria (CIU) are common causes of substantial illness and disability in preschool children. Antihistamines are commonly used to treat preschool children with these conditions, but their use is based mostly on extrapolated efficacy from adult populations; it is thus important to characterize the safety of antihistamines in the pediatric population. This study was designed to assess the safety of levocetirizine dihydrochloride oral liquid drops in infants and children with AR or CIU. Two multicenter, double-blind, randomized, parallel-group studies randomized infants aged 6-11 months (study 1, n = 69) and children aged 1-5 years (study 2, n = 173) to levocetirizine, 1.25 mg (q.d. or b.i.d., respectively), or placebo for 2 weeks, using a 2:1 ratio. Safety evaluations included treatment-emergent adverse events (TEAEs), vital signs, electrocardiographic (ECG) assessments, and laboratory tests. The overall incidence of TEAEs was similar between levocetirizine and placebo in both studies. Most TEAEs were mild or moderate in intensity. TEAEs prompted discontinuation of therapy in three patients receiving levocetirizine in study 1. No clinically relevant changes from baseline in vital signs or laboratory parameters were apparent in either study; changes from baseline in these evaluations were similar between groups. No significant changes were observed in ECG parameters, including corrected QT interval. Levocetirizine, 1.25 and 2.5 mg/day, was well tolerated in infants aged 6-11 months and in children aged 1-5 years, respectively, with AR or CIU.

Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases

“…The 12‐week study duration was in accordance with EMA guidelines for clinical development of medicinal products for treatment of allergic rhinoconjunctivitis in children. Bilastine thus joins cetirizine , levocetirizine and loratadine as second‐generation H 1 antihistamines approved for use in paediatric patients for which long‐term safety data are available.…”

Rupatadine is effective in the treatment of chronic spontaneous urticaria in children aged 2–11 years

“…The extrapolation strategy was used for loratadine by means of safety and pharmacokinetic study in children over 2 years . Levocetirizine, in atopic children aged 1–2 years, was evaluated for its safety in a placebo‐controlled trial lasting 18 months and in a short‐term trial in infants aged 6–12 months and children aged 1–5 years . Desloratadine can be given to children aged 1 year and older, but only extrapolation from safety data was obtained in children .…”

Evidence for Clinical Safety, Efficacy, and Parent and Physician Perceptions of Levocetirizine for the Treatment of Children with Allergic Disease

“…Similarly, assessment of change in electrocardiogram parameters showed no significant changes in levocetirizine or placebo-treated groups in both studies, and none of the patients had a prolonged corrected QT interval. These findings suggest that levocetirizine 1.25 mg/day is very well tolerated in infants as young as 6 months of age and that 2.5 mg/day is a well-tolerated dose for 1- to 5-year-old children with AR or CIU [63]. …”

“…More recently, two randomised, double-blind, parallel-group, placebo-controlled, multi-centre studies have specifically investigated the safety of treatment with levocetirizine 1.25 mg and matched placebo, once or twice daily, for 2 weeks, in 69 infants aged 6–11 months and 173 children aged 1–5 years, respectively, with AR or CIU [63]. The two study cohorts were treated with levocetirizine or placebo using a ratio of 2:1, and safety of treatment was evaluated according to treatment-emergent adverse events, changes in weight, vital signs, electrocardiogram parameters and haematologic and biochemical laboratory tests.…”