Evidence map›Paper›PMID 21663330›Full record

ReviewDrug safety2011

Association between leukotriene-modifying agents and suicide: what is the evidence?

Glen T Schumock, Todd A Lee, Min J Joo, Robert J Valuck, Leslie T Stayner, Robert D Gibbons

Abstract readReview
PubMed Publisher
In one paragraph

Review in Drug safety, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Neuropsychiatric events associated with montelukast in patients with asthma: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2023
    Pooled it
  3. Article
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  12. Review
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  16. Depression symptoms and quality of life among individuals with aspirin-exacerbated respiratory disease.The Journal of asthma : official journal of the Association for the Care of Asthma · 2019
    Article
  17. Article
  18. Article
  19. Methods for identifying suicide or suicidal ideation in EHRs.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2012
    Article
  20. Achieving symptom control in patients with moderate asthma.Clinical medicine insights. Circulatory, respiratory and pulmonary medicine · 2012
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Glen T SchumockCenter for Pharmacoeconomic Research, University of Illinois at Chicago, USA. Schumock@uic.edu
Todd A Lee
Min J Joo
Robert J Valuck
Leslie T Stayner
Robert D Gibbons
University of Illinois Chicago · USUniversity of Colorado Denver · US

Funding

Antidepressant Treatment and Suicidality: Biostatistical/Methodological SolutionsR01MH080122 · NIMH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI GIBBONS, ROBERT D · 2008 to 2011
$2.7M
NIMH NIH HHS R01 MH080122
6 · The paper itself

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 case-control 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.

Indexed as

AcetatesAdverse Drug Reaction Reporting SystemsCyclopropanesDrug LabelingHumansHydroxyureaIndolesLeukotriene AntagonistsPhenylcarbamatesQuinolinesSuicideSulfidesSulfonamidesTosyl CompoundsUnited StatesUnited States Food and Drug AdministrationAcetatesCyclopropanesHydroxyureaIndolesLeukotriene AntagonistsmontelukastPhenylcarbamatesQuinolinesSulfidesSulfonamidesTosyl Compoundszafirlukastzileuton

Identifiers

PMID21663330
OpenAlexW130378437

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.