The Impact of Montelukast’s Black Box Warning on Pediatric Mental Health Adverse Event Reports

OBJECTIVE: In March 2020, the US Food and Drug Administration (FDA) required a black box warning for montelukast due to serious mental health side effects. We hypothesized the warning would lead to an overall decrease in reports of mental health symptoms and disorders related to montelukast in both -pre-adolescent and adolescent groups. METHODS: Adverse events of pre-adolescent and adolescent children taking montelukast sodium were reviewed from March 1, 2018 to March 3, 2020 and March 4, 2020 to February 28, 2022 using the FDA's Adverse Events Reporting System. The objective was to determine if mental health adverse event reports were influenced by placement of a Boxed Warning. Adverse reactions were grouped into 8 categories deemed to be related to mental health guided by the research team's interpretation of the FDA Sentinel Report. Chi-square tests were used to compare time periods and reports of the mental health categories. RESULTS: (1) = 8.5, p = 0.004). CONCLUSIONS: After placement of an FDA black box warning on montelukast, total number of reports -including mental health adverse events decreased in pre-adolescents; however, several categories -assessed increased for adolescents.