Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a matched nested case‐control study

Ali, Mir M.; O’Brien, Catherine E.; Cleves, Mario A.; Martin, Bradley C.

doi:10.1002/pds.3758

Cited by 36 publications

(44 citation statements)

References 41 publications

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“…In 2009, the US Food and Drug Administration mandated a label change for montelukast and other leukotriene receptor antagonists to include neuropsychiatric adverse events (e.g., depression and suicidality) as a precaution (FDA, 2017). Nonetheless, Ali could not establish a significant association between montelukast and neuropsychiatric events in children with asthma (Ali et al 2015).…”

Section: Discussionmentioning

confidence: 83%

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Adverse drug reactions of montelukast in children and adults

Haarman

Hunsel

Vries

2017

Pharmacology Res & Perspec

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Montelukast, a selective leukotriene receptor antagonist, is recommended in guidelines for the treatment of asthma in both children and adults. However, its effectiveness is debated, and recent studies have reported several adverse events such as neuropsychiatric disorders and allergic granulomatous angiitis. This study aims to obtain more insight into the safety profile of montelukast and to provide prescribing physicians with an overview of relevant adverse drug reactions in both children and adults. We retrospectively studied all adverse drug reactions on montelukast in children and adults reported to the Netherlands Pharmacovigilance Center Lareb and the WHO Global database, VigiBase® until 2016. Depression was reported most frequently in the whole population to the global database VigiBase® (reporting odds ratio (ROR) 6.93; 95% CI: 6.5–7.4). In the VigiBase®, aggression was reported the most in children (ROR, 29.77; 95% CI: 27.5–32.2). Headaches were reported the most frequently to the Dutch database (ROR, 2.26; 95% CI: 1.61–3.19). Furthermore, nightmares are often reported for both children and adults to the Dutch and the global database. Eight patients with allergic granulomatous angiitis were reported to the Dutch database and 563 patients in the VigiBase®. These data demonstrate that montelukast is associated with neuropsychiatric adverse drug reactions such as depression and aggression. Especially in children nightmares are reported frequently. Allergic granulomatous angiitis is also reported, a causal relationship has not been established.

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Section: Discussionmentioning

confidence: 83%

“…Nonetheless, Ali could not establish a significant association between montelukast and neuropsychiatric events in children with asthma (Ali et al. ).…”

Section: Discussionmentioning

confidence: 99%

Adverse drug reactions of montelukast in children and adults

Haarman

Hunsel

Vries

2017

Pharmacology Res & Perspec

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“…Thirty-three studies, including two non-English studies [12,25], were selected for a narrative review. The study types include cohort studies (n = 2) [21,23], nested case-control studies (n = 2) [22,24], pharmacovigilance studies (n = 10) [4][5][6][7][8][9][10][11][12][13], ITS analysis (n = 2) [26,27], case series (n = 1) [28], case reports (n = 6) [29][30][31][32][33][34], review of case reports (n = 1) [25], and conference abstracts (n = 9) [35][36][37][38][39][40][41][42][43]. Of the included articles, twelve studies reported suicidal conditions as one of the outcomes [6, 10, 11, 21-23, 25, 26, 32, 36, 37, 40].…”

Section: Search Resultsmentioning

confidence: 99%

“…Observational studies could complement the findings of RCTs since they have greater generalisability and longer follow-up time. With the concerns about the neuropsychiatric safety of LTMAs, some observational and pharmacovigilance studies were conducted to examine this association [4][5][6][7][8][9][10][11][12][13][21][22][23][24]. This review aims to systematically evaluate the evidence from the published literature of different study designs to investigate the association between NEs and LTMAs.…”

Section: Introductionmentioning

confidence: 99%

Neuropsychiatric Events Associated with Leukotriene-Modifying Agents: A Systematic Review

et al. 2017

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“…Recently, Ali et al examinated this association among children with asthma and 1920 subjects less than 18 years of age with a primary diagnosis of asthma between 1 January 1998 and 31 December 2009 were identified. A clear dose-response relationship was not observed, with an adjusted OR of 1.01 (95 % CI [0.88, 1.14] for experiencing NE [123, 124]. …”

Section: Introductionmentioning

confidence: 99%

Asthma phenotypes: the intriguing selective intervention with Montelukast

Cottini¹,

Lombardi

2016

asthma res and pract

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Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation and a variable course associated with various underlying mechanisms that can differ between individuals. Patients with asthma can therefore exhibit different phenotypes, a term used to define the observable characteristics of an organism resulting from the interaction between its genetic makeup and the environment. The heterogeneity of asthma has received a large amount of attention in the last few years in order to better tailor treatment according to the different clinical and biological phenotypes of the disease. Specific asthma phenotypes may require an approach to treatment sometimes different from that recommended by current guidelines, so a personalized approach to asthma pharmacotherapy is recommended. Growing evidence suggests that leukotrienes play an important role in the pathogenesis of bronchial asthma. The mechanisms of action of leukotriene-receptor antagonists theoretically predict a good response in some asthma “phenotypes”.In this article we have performed an analysis of the recent literature (controlled clinical trials and real-life studies) about a possible selective intervention with Montelukast in specific asthma phenotypes.

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Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a matched nested case‐control study

Abstract: These data did not detect a consistent significant positive association between montelukast and NE in children with asthma.

Cited by 36 publications

References 41 publications

Adverse drug reactions of montelukast in children and adults

Adverse drug reactions of montelukast in children and adults

Neuropsychiatric Events Associated with Leukotriene-Modifying Agents: A Systematic Review

Asthma phenotypes: the intriguing selective intervention with Montelukast

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