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Levocetirizine-induced Psychiatric Disorders in a Pediatric Patient: A Case Report and a Pharmacovigilance Database Analysis

C. Carnovale, S. Russo, G. Biondelli, M. Gentili, M. Pozzi, S. Antoniazzi, S. Radice, E. Clementi

Journal of Pharmacology and Pharmacotherapeutics, 2017

2 citations

Abstract

Sir, Levocetirizine is a third‐generation antihistamine drug with high selectivity for H1‐receptors that is commonly prescribed for the treatment of allergic diseases in children. The safety data from the clinical trials on administration over long periods and in almost all pediatric age groups suggest that levocetirizine use is safe and it is not associated with relevant adverse effects on the central nervous system (CNS).[1] However, recent postmarketing surveillance studies have reported cases of aggression, hyperactivity, and agitation in pediatric patients using levocetirizine.[2,3] In addition, it has been suggested that levocetirizine possibly leads to hallucinations and suicidal ideation.[2] The relevance of these psychiatric disorders in clinical practice, the pharmacological mechanisms likely involved and the causal relationship with levocetirizine use have not yet been investigated.

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Evidence Hub reads this as a case report, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.

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