Incidence of cessation of montelukast due to a neuropsychiatric adverse drug reaction (ADR)

ADR nMontelukast cohortSensitivity analyses
Including nonparticipants who denied montelukast intake, but had confirmed drug claims#Including all nonparticipants
Patients n106124223
ADR reported by parents1716 (10–26)14 (9–22)8 (5–12)
ADR confirmed by the adjudication committee+1312 (7–21)10 (6–18)6 (3–10)

Data are presented as incidence (95% CI), unless otherwise stated. #: assuming that none of the 18 out of 50 nonparticipants who denied having taken montelukast (but in whom we had confirmed dispensing in the drug claim database) had a drug cessation due to a neuropsychiatric ADR; : assuming that none of the 117 nonparticipants (not contacted, refused to participate or who denied having taken montelukast) had a drug cessation due to a neuropsychiatric ADR; +: ascertained as definite (≥9; n=0) or probably (5–8; n=13) related to the drug on the Naranjo causality scale. Of note, the causality assessment was identical whether the adjudicator assumed that the ADR was related to inhaled corticosteroid or to montelukast.