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Risk of Psychiatric Adverse Events Among Montelukast Users

Published:August 10, 2020DOI:https://doi.org/10.1016/j.jaip.2020.07.052

      Background

      There have been conflicting results from observational studies regarding the risk of psychiatric adverse events (PAEs) with montelukast use.

      Objective

      To determine whether there are associations of depressive disorders, self-harm, and suicide with use of montelukast compared with inhaled corticosteroid (ICS) use.

      Methods

      Using data from the Sentinel Distributed Database from January 1, 2000, to September 30, 2015, patients (n = 457,377) exposed to montelukast or ICS, aged 6 years and older with a diagnosis of asthma, were matched 1:1 on propensity scores. Hazard ratios (HRs) and 95% CIs were estimated for each study outcome overall and by age, sex, psychiatric history, and pre-/post-2008 labeling updates using Cox proportional hazards regression models.

      Results

      Exposure to montelukast was associated with a lower risk of treated outpatient depressive disorder (HR, 0.91; 95% CI, 0.89-0.93). No increased risks of inpatient depressive disorder (HR, 1.06; 95% CI, 0.90-1.24), self-harm (HR, 0.92; 95% CI, 0.69-1.21), or self-harm using a modified algorithm (HR, 0.81; 95% CI, 0.63-1.05) were observed with montelukast use compared with ICS use. Most PAEs occurred in the roughly one-third of patients having a past psychiatric history.

      Conclusions

      When compared with use of ICS, we did not find associations between montelukast use and hospitalizations for depression or self-harm events. Our findings should be interpreted considering the study's limitations. Psychiatric comorbidity was common, and most PAEs occurred in patients with a past psychiatric history.

      Key words

      Abbreviations used:

      HR (Hazard ratio), ICS (Inhaled corticosteroid), LABA (Long-acting beta-agonist), LTMA (Leukotriene-modifying agent), PAE (Psychiatric adverse event)
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