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Montelukast, approved by the FDA in 1998, is a widely prescribed leukotriene receptor antagonist for asthma, exercise-induced bronchoconstriction, and allergic rhinitis. Concerns about its neuropsychiatric side effects prompted several FDA labeling updates, including an update to the patient and prescribing information to include several post-marketing adverse events including depression, suicidality, and anxiety in 2007, an update to the “precautions” of drug’s prescribing information in 2009, ultimately a Black Box Warning in 2020. This study aimed to analyze prescribing trends of montelukast before and after FDA safety warnings using data from the National Ambulatory Medical Care Survey (NAMCS) for 2003–2019.
This observational, retrospective, cross-sectional study included outpatient visits for patients aged two years and older with respiratory complaints. This study was deemed not human subject research by the Campbell University Institutional Review Board due to the nature of the publicly available de-identified database. The primary outcome was the proportion of visits with montelukast. The primary predictor compared two periods: 2003–2007 (pre-warning) and 2008–2019 (post-warning). Secondary and tertiary analyses assessed prescribing trends and the association of demographic and clinical factors available in the dataset with montelukast use. Statistical methods included a plot of the proportion of visits with montelukast by year and a multivariable logistic regression model (MLRM).
Findings showed a slight decline in montelukast prescribing, from 5.3% of visits in 2003–2007 to 4.4% in 2008–2019 (OR 0.89, 95% CI 0.70–1.14, from the MLRM after adjusting for covariates). The plot of the annual proportion of visits with montelukast revealed a slight decline in prescribing over time, with a significant drop in prescribing after 2007, coinciding with updated FDA safety information. The MLRM provided no evidence of significant predictors or the identification of disparities between groups/levels of demographic variables.
The findings suggest that FDA safety communications and the introduction of alternative therapies may have influenced prescribing practices.
