Use of montelukast not associated with risk of neuropsychiatric adverse events among children: JAMA

Results The final cohort included 74 291 children (mean [SD] age, 12.3 [3.3] years; 35 446 female [47.7%]); 26 462 used montelukast and 47 829 used LABA. During a mean (SD) follow-up of 5.8 (3.2) months, 310 neuropsychiatric adverse events in the montelukast patients and 566 events in the LABA patients were identified. In the weighted cohort, the incidence rates of neuropsychiatric adverse events were 2.39 per 100 patient-years among the montelukast users and 2.41 per 100 patient-years among the LABA users.

This translated to a weighted HR of 0.99 (95% CI, 0.84-1.16). No substantial differences were observed between the montelukast and LABA patients when analyzing the risk of specific neuropsychiatric adverse events: the HRs were 0.79 (95% CI, 0.54-1.14) for anxiety; 1.16 (95% CI, 0.70-1.95) for depression; 0.93 (95% CI, 0.76-1.13) for sleep-related disorders; 1.31 (95% CI, 0.64-2.69) for suicide and suicidal actions; 1.27 (95% CI, 0.84-1.90) for disrupted control of activity, attention, and behaviour; and 0.51 (95% CI, 0.05-5.53) for confusion and psychotic-like symptoms. The risk of the primary outcome was consistent over subgroups and a range of sensitivity analyses. In this large study of children and adolescents based on data from routine clinical practice, there was no association between the use of montelukast and the risk of neuropsychiatric adverse events. In aggregation with other robust observational studies, these results can inform the management of asthma and allergic rhinitis in this patient group.

Reference:

Wintzell V, Brenner P, Halldner L, Rhedin S, Gong T, Almqvist C. Montelukast Use and the Risk of Neuropsychiatric Adverse Events in Children. JAMA Pediatr. Published online January 21, 2025. doi:10.1001/jamapediatrics.2024.5429