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Association between Leukotriene-Modifying Agents and Suicide

What is the Evidence?

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Abstract

The US FDA has issued safety alerts and required manufacturers of leukotriene-modifying agents (LTMAs), including montelukast, zafirlukast and zileuton, to include suicide and neuropsychiatric events as a precaution in the drug label. This paper reviews the existing evidence on the potential association between the LTMAs and suicidal behaviour. We conducted a literature search of MEDLINE, EMBASE and International Pharmaceutical Abstracts from 1995 to 2010 (inclusive) to identify pertinent studies and reports. We also examined data obtained from the FDA adverse event reporting system. To date, there are no well conducted, comparative, observational studies of this association, and the safety alerts are based primarily on case reports. While the FDA safety alerts apply to all three LTMAs, montelukast (known by its trade name Singulair®) is by far the most widely used of these drugs and most of the reports to date regarding suicide pertain to montelukast. From 1998 to 2009 there were 838 suicide-related adverse events associated with leukotrienes reported to the FDA, of which all but five involved montelukast. Nearly all cases were reported in 2008 and 2009 (96.1%) after the FDA warnings. LTMAs are approved for use in asthma and allergic rhinitis, and are effective drugs. Both of these diseases are also associated with suicide, making confirmation of the association more difficult. Given the lack of good evidence, we recommend that a large observational cohort or casecontrol study be conducted to quantify the association between LTMAs and suicide. Until then, when prescribing LTMAs, clinicians should consider the potential for suicide and monitor patients who may be at elevated risk carefully for suicidal ideation or psychiatric symptoms associated with suicidal behaviour.

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Acknowledgements

There was no funding received for the preparation of this review. All persons who made substantial contributions to the work are included as authors. Dr Gibbons previously served as an expert witness for the US Department of Justice and Wyeth (now part of Pfizer, Inc.) and Pfizer, Inc. on matters related to drug-associated suicide. Dr Lee has received grant funding for other work related to asthma and respiratory diseases from Merck & Co., Inc. and Novartis. Dr Schumock has served as a consultant for Boehringer-Ingelheim. Dr Valuck has served as a paid consultant for Eli Lilly and Company, Forest Research Institute, and H. Lundbeck A/S to study antidepressant drugs and various clinical conditions (depression, suicide, drug interactions). Drs Joo and Stayner have no conflicts of interest to report.

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Authors and Affiliations

  1. Center for Pharmacoeconomic Research, University of Illinois at Chicago, Chicago, IL, USA

    Glen T. Schumock & Todd A. Lee

  2. Department of Pharmacy Practice, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA

    Glen T. Schumock & Todd A. Lee

  3. Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA

    Glen T. Schumock, Todd A. Lee, Leslie T. Stayner & Robert D. Gibbons

  4. Center for Management of Complex Chronic Care, Hines VA Hospital, Hines, IL, USA

    Todd A. Lee

  5. Section of Pulmonary, Critical Care, Sleep and Allergy, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA

    Min J. Joo

  6. Department of Clinical Pharmacy, University of Colorado, Denver, CO, USA

    Robert J. Valuck

  7. Center for Health Statistics, Pritzker School of Medicine, University of Chicago, Chicago, IL, USA

    Robert D. Gibbons

  8. Department of Medicine and Health Studies, Pritzker School of Medicine, University of Chicago, Chicago, IL, USA

    Robert D. Gibbons

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Correspondence to Glen T. Schumock.

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Schumock, G.T., Lee, T.A., Joo, M.J. et al. Association between Leukotriene-Modifying Agents and Suicide. Drug-Safety 34, 533–544 (2011). https://doi.org/10.2165/11587260-000000000-00000

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