Citation

Schumock GT, Gibbons RD, Lee TA, Joo MJ, Stayner LT, Valuck RJ. Drug Inf. J. 2012; 46(1): 99-106.

Copyright

(Copyright © 2012, Drug Information Association)

DOI

10.1177/0092861511427856

PMID

unavailable

Abstract

The purpose of this study was to examine the association between leukotriene-modifying agents (LTMAs) and completed suicide. Data from the Food and Drug Administration (FDA) Adverse Event Reporting System from 1999 to 2009 were used to identify the number of completed suicides for each LTMA. Data from IMS Health were used to determine the number of prescriptions dispensed by drug in the same time period. The authors calculated the rate of completed suicides per million prescriptions and, using a mixed-effects Poisson regression analysis, determined the empirical Bayes (EB) rate multipliers and 95% confidence intervals for each drug. Selective serotonin-reuptake inhibitors (SSRIs) and short-acting beta-agonist (SABAs) were analyzed for comparison purposes. There were 105 completed suicides reported where a LTMA was implicated. Most (n = 101) involved montelukast, and all but 9 occurred in 2008 to 2009, following an FDA warning. Aggregated suicide rates over the 1999-2009 period were 0.51, 0.24, and 4.09 per million prescriptions for montelukast, zafirlukast, and zileuton. The suicide rate as a class was 0.06 per million prescriptions in the prewarning period and 1.82 per million prescriptions in the postwarning period. Montelukast was associated with a significantly lower rate of suicide when compared to SSRIs and a significantly higher rate when compared to SABAs. © Drug Information Association 2012.

Language: en

Keywords

human; suicide; article; prescription; citalopram; fluoxetine; fluvoxamine; paroxetine; serotonin uptake inhibitor; sertraline; priority journal; drug safety; food and drug administration; beta adrenergic receptor stimulating agent; escitalopram; drug surveillance program; montelukast; orciprenaline; salbutamol; zafirlukast; zileuton; leukotriene receptor blocking agent; selective serotonin reuptake inhibitors; levalbuterol; pirbuterol; Food and Drug Administration; leukotriene-modifying agents; short-acting beta-agonists