Veronica Sansing-Foster1, Nicole Haug2, Andrew Mosholder1, Noelle M Cocoros2, Marie Bradley1, Yong Ma3, Dinci Pennap1, Elizabeth C Dee2, Sengwee Toh2, Ella Pestine2, Andrew B Petrone2, Ivone Kim4, Jennifer G Lyons2, Efe Eworuke5. 1. Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Md. 2. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass. 3. Division of Biometrics, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Md. 4. Division of Pharmacovigilance, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Md. 5. Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Md. Electronic address: Efe.Eworuke@fda.hhs.gov.
Abstract
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. Published by Elsevier Inc.
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 outpatientdepressive 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. Published by Elsevier Inc.
Authors: James W Antoon; James A Feinstein; Carlos G Grijalva; Yuwei Zhu; Emily Dickinson; Justine C Stassun; Jakobi A Johnson; Mert Sekmen; Yasas C Tanguturi; James C Gay; Derek J Williams Journal: Hosp Pediatr Date: 2022-05-01
Authors: Ira S Rostevanov; Batya Betesh-Abay; Ahmad Nassar; Elina Rubin; Sarit Uzzan; Jacob Kaplanski; Linoy Biton; Abed N Azab Journal: Front Immunol Date: 2022-09-06 Impact factor: 8.786