The Association Between Leukotriene-Modifying Agents and Spontaneously Reported Suicide
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The Association Between Leukotriene-Modifying Agents and Spontaneously Reported Suicide
Drug Information Journal 46(1) 99-106 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861511427856 http://dij.sagepub.com
Glen T. Schumock, PharmD, MBA1, Robert D. Gibbons, PhD2, Todd A. Lee, PharmD, PhD3, Min J. Joo, MD, MPH4, Leslie T. Stayner, PhD5, and Robert J. Valuck, PhD6
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 ¼ 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. Keywords suicide, leukotriene-modifying agents, drug safety, Food and Drug Administration, selective serotonin reuptake inhibitors, shortacting beta-agonists
Introduction Suicide is a significant public health issue both in the United States, where it is the 11th leading cause of death, and worldwide.1 Although there are many causes and risk factors for suicide, over the past 5 years, there has been an increasing recognition of the potential association between use of certain prescription medications and suicide.2 The US Food and Drug Administration (FDA) has issued warnings about psychiatric symptoms and suicidality for entire classes of medications, including antidepressants,3–8 antiepileptic drugs (AEDs),9 and, more recently, leukotriene-modifying agents (LTMAs).10–12 The LTMAs, which in the United States include montelukast (Singulair; Merck & Co, Whitehouse Station, New Jersey), zafirlukast (Accolate; AstraZeneca Pharmaceuticals, Wilmington, Delaware), and zileuton (Zyflo; Cornerstone Therapeutics, Cary, North Carolina), are an important class of medications
1 Center for Pharmacoeconomic Research and Department of Pharmacy Practice, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA 2 Center for Health S
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