RT Journal Article
SR Electronic
T1 Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1700148
DO 10.1183/13993003.00148-2017
VO 50
IS 2
A1 Brigitte Benard
A1 Valérie Bastien
A1 Benjamin Vinet
A1 Roger Yang
A1 Maja Krajinovic
A1 Francine M. Ducharme
YR 2017
UL http://erj.ersjournals.com/content/50/2/1700148.abstract
AB Although montelukast is generally well tolerated, postmarketing studies have reported serious neuropsychiatric adverse drug reactions (ADRs) leading to a United States Food and Drug Administration warning. The objective of this study was to determine the incidence of neuropsychiatric ADRs leading to discontinuation of montelukast in asthmatic children.We conducted a retrospective cohort study in children aged 1–17 years initiated on montelukast. In a nested cohort study, children initiated on montelukast as monotherapy or adjunct therapy to inhaled corticosteroids (ICS) were matched to those initiated on ICS monotherapy. A non-leading parental interview served to ascertain the occurrence of any ADRs with any asthma medication, and circumstances related to, and evolution of, the event.Out of the 106 participants who initiated montelukast, most were male (58%), Caucasian (62%) with a median (interquartile range) age of 5 (3–8) years. The incidence (95% CI) of drug cessation due to neuropsychiatric ADRs was 16 (10–26)%, mostly occurring within 2 weeks. Most frequent ADRs were irritability, aggressiveness and sleep disturbances. The relative risk of neuropsychiatric ADRs associated with montelukast versus ICS was 12 (2–90).In the real-life setting, asthmatic children initiated on montelukast experienced a notable risk of neuropsychiatric ADRs leading to drug cessation, that is significantly higher than that associated with ICS.The incidence of children on montelukast with drug cessation due to neuropsychiatric adverse events was >10% http://ow.ly/nCGG30bgjpd