Abstract
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.
Abstract
The incidence of children on montelukast with drug cessation due to neuropsychiatric adverse events was >10% http://ow.ly/nCGG30bgjpd
Footnotes
This article has been revised according to the correction published in the November 2017 issue of the European Respiratory Journal.
This article has supplementary material available from erj.ersjournals.com
Support statement: This work has been funded by unrestricted donations to the Academic Chair in Clinical and Knowledge Transfer Research on Childhood Asthma of the Sainte-Justine University Health Centre. Funding information for this article has been deposited with the Crossref Funder Registry.
Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com
- Received January 20, 2017.
- Accepted April 20, 2017.
- Copyright ©ERS 2017
