Purpose: A signal has been raised concerning montelukast and adverse drug reactions (ADRs) in children. The purpose of the present study was to evaluate psychiatric ADRs during treatment with montelukast in children.
Methods: We analyzed all reports of psychiatric disorders during treatment with montelukast in children (<18 years) in the Swedish ADR database SWEDIS (1998-2007). The Bayesian Confidence Propagation Neural Network (BCPNN) method was used to screen for disproportional reporting rates of these reactions. An information component (IC) with a positive 95% lower confidence limit indicates a statistically significant disproportionality between the expected and the reported rate for a drug and an ADR.
Results: A total of 48 reports of psychiatric disorders in children during treatment with montelukast were found in SWEDIS. Reports appeared every year after registration. Psychiatric disorders reported more than once included nightmares (n = 15), unspecified anxiety (n = 11), aggressiveness (n = 11), sleep disorders (n = 10), insomnia (n = 3), irritability (n = 3), hallucination (n = 3), hyperactivity (n = 3), and personality disorder (n = 2). In 23 reports (48%), the child experiencing psychiatric ADRs was < or = 3 years old. Time from exposure to ADR was indicated in 35 reports. In 28 of these (80%), the time from exposure to ADR was less than 1 week. A statistical signal for psychiatric disorders appeared in the fourth quarter of 1998 (three reports, IC-value: 2.34, 95% lower confidence limit: 0.62).
Conclusions: Psychiatric ADRs can occur during montelukast treatment in children, indicating that attention to this is essential. Further studies are needed to establish the magnitude of the problem.