Neuropsychiatric adverse drug reactions induced by montelukast impair the quality of life in children with asthma

Bayer, Oznur Yilmaz; Türktaş, İpek; Karagöl, Hacer İlbilge Ertoy; Soysal, Şebnem; Yapar, Dilek

doi:10.1080/02770903.2020.1861626

Cited by 11 publications

(13 citation statements)

References 24 publications

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“…Yılmaz Bayer et al 17 reported neuropsychiatric ADRs among 62.4% of 125 patients aged 3-18 years using montelukast. Posttreatment temperamental behavior, nightmares, and sleep disorders were significantly more frequent than pretreatment.…”

Section: Resultsmentioning

confidence: 99%

“…They remarked that montelukast-associated neuropsychiatric ADRs are more common than they are reported in the literature and negatively affect the quality of life of children. 17 In a meta-analysis involving 15 studies, Dixon et al 18 reported that "anxiety," "sleep disturbances," and "mood disorders" were the most frequently reported ADRs in 7012 cases aged 0-18 years using LTRA. They remarked that the side effects associated with LTRAs are predominantly gastrointestinal and neuropsychiatric disorders.…”

Section: Limitations Of the Studymentioning

confidence: 99%

“…9,10,22 In addition to the fact that neuropsychiatric adverse events constitute the most important costs associated with comorbidity in asthma, their negative effects on the quality of life of patients should not be ignored either. 9,17 Although most of the neuropsychiatric disorders and sleep disturbances affecting the pediatric population more frequently improved clinically following the discontinuation of montelukast, their negative effects on the quality of life of patients in the long term are still unknown. 3,4,9 The psychiatric evaluation that we planned in our study could not be performed because the families did not give consent.…”

Section: Limitations Of the Studymentioning

confidence: 99%

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Adverse drug reactions affecting treatment adherence in first-line treatment of asthma: An observational study

Erdem

Nacaroğlu²,

Can³

2023

Allergol Immunopathol

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Background: Asthma is the most common chronic lung disease among children. International guidelines recommend inhaled corticosteroids (ICS) as the first-line daily controller therapy for children with asthma and leukotriene receptor antagonists (LTRA) as the second alternative therapy. Adherence to treatment is the most significant component to optimize the benefits of therapy in asthma. Objective: This study aims to investigate the frequency of drug discontinuation due to adverse drug reactions (ADRs) that affect adherence to treatment in children with asthma or asthma and allergic rhinitis using LTRA or ICS as monotherapy. Methods: The subjects aged 4–18 years with asthma or asthma and allergic rhinitis and using montelukast or ICS as monotherapy were included in the study. They were evaluated in terms of ADRs affecting adherence to treatment in the first and third months of treatment. Results: A total of 468 cases, 356 of whom received montelukast monotherapy and 112 of whom received ICS treatment, with a mean age of 9.10 ± 3.08 (4–17) years, were included in the study. Males constituted 65.6% of the total cases (n = 307). In the first month of follow-up of the cases, it was observed that 4.8% (n = 17) of the patients in the montelukast group could not continue the treatment due to ADR. It was determined that the drug discontinuation rate in the montelukast group in the first month was significantly higher than in the ICS group (P = 0.016), and the risk of drug discontinuation due to ADR in the montelukast group was 1.333 (95% CI, 1.26–1.40) times higher. Conclusions: As a result, it was observed that the drug was discontinued due to ADR at a higher rate in children with asthma who received montelukast monotherapy compared to those who received ICS monotherapy.

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Section: Resultsmentioning

confidence: 99%

Section: Limitations Of the Studymentioning

confidence: 99%

Section: Limitations Of the Studymentioning

confidence: 99%

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Adverse drug reactions affecting treatment adherence in first-line treatment of asthma: An observational study

Erdem

Nacaroğlu²,

Can³

2023

Allergol Immunopathol

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“…The FDA reviewed 82 cases of suicide events associated with the use of montelukast and has warned of neuropsychiatric events since 2009 [ 20 ]; however, other observational studies found no association between montelukast use and neuropsychiatric events [ 29 , 30 ]. Compared with the pretreatment stage, temperamental behavior, nightmares, and sleep disorders occurred significantly more frequently in both age groups, 3–7 and 8–18 years, with montelukast in an observational study, and quality-of-life scores were significantly affected in both children and parents [ 31 ]. Bernard et al reported an incidence of neuropsychiatric ADRs following montelukast of 16% (95% CI: 10–26), the most frequent of which were irritability, aggressiveness, and sleep disturbance in a nested cohort study [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

Increased Risk of Tourette Syndrome with Leukotriene Modifier Use in Children with Allergic Diseases and Asthma: A Nationwide Population-Based Study

et al. 2022

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(1) Background: Cysteinyl leukotriene receptor antagonists (LTRAs), including montelukast and zafirlukast, are FDA-approved for treating pediatric asthma and allergic diseases. Tourette syndrome (TS), a common neuropsychiatric disorder in children, is associated with allergic diseases and asthma. In this study, we investigated the risk of TS following an LTRA prescription for pediatric allergic diseases. (2) Methods: Children younger than 18 years of age who were newly diagnosed with asthma, allergic rhinitis, or atopic dermatitis between 1 January 2005 and 31 December 2018 and who were registered in the Taiwan National Health Insurance Research Database, which comprises the medical records of nearly 23 million Taiwanese population, were enrolled. LTRA users were matched with randomly selected LTRA non-users by sex, age, asthma-diagnosis year, and urbanization level. In total, 26,984 participants with allergic disease and TS were enrolled and included in the Cox proportional hazards model analysis. (3) Results: Children with allergic disease and asthma treated with LTRAs had a higher risk for TS than LTRA non-users (adjusted hazard ratio 1.376 [95% CI: 1.232–1.536], p < 0.001). LTRA users had a significantly higher risk for TS than LTRA non-users with allergic disease. The cumulative incidence of TS was significantly higher in LTRA users than in non-users with allergic diseases and asthma (log-rank test, p < 0.0001). (4) Conclusion: A prescription of LTRAs, mainly montelukast, increased the risk of TS among children with asthma, allergic rhinitis, or atopic dermatitis. The mechanism underlying the neuropsychiatric effect of LTRAs needs further investigation.

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“… 6 Some studies have found that neuropsychiatric adverse drug reactions can impair the quality of life in children with asthma. 23 Therefore, children especially preschool children should be paid more attention to the occurrence of neuropsychiatric symptoms.…”

Section: Discussionmentioning

confidence: 99%

Neuropsychiatric side reactions of leukotriene receptor antagonist, antihistamine, and inhaled corticosteroid: A real-world analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS)

Bian

Wang

et al. 2021

World Allergy Organization Journal

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Background There are limited real-world studies on the differences in leukotriene receptor antagonists (LTRA), H1-antihistamines (H1-AH), and inhaled corticosteroids (ICS) associated neuropsychiatric events. In this study, we aimed to analyze the characteristics of drug associated neuropsychiatric events, and compare the differences among different drug categories. Methods Disproportionality analysis and Bayesian analysis were used in data mining to identify suspected neuropsychiatric events associated with LTRA, H1-AH, and ICS based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2004 to September 2020. Demographic information, time interval to onset, and death rates of LTRA, H1-AH, and ICS-associated neuropsychiatric events were also analyzed. Results A total of 9475 neuropsychiatric events were identified. The number of neuropsychiatric events related to LTRA, H1-AH, and ICS were 5201 (54.89%), 3226 (34.05%), and 1048 (11.06%), respectively. LTRA related neuropsychiatric events were more common in patients aged 4–6 years (18.66%). H1-AH and ICS related neuropsychiatric events were more common in patients aged 18–44 years (29.92%) and older than 65 years (30.60%), respectively. Montelukast was highly associated with neuropsychiatric events, with a high reporting odds ratio (ROR). Most neuropsychiatric symptoms occurred within the first 10 days after drug initiation (78.63% for LTRA, 91.39% for H1-AH, and 84.07% for ICS). The death rate due to neuropsychiatric events of first generation H1-AH was significantly higher than that of LTRA and ICS (p < 0.001). Conclusions LTRA associated neuropsychiatric events reported in FAERS were most frequent in 4 to 6-year-old children. Most reported cases occurred within the first 10 days after drug initiation. The second generation H1-AH was relatively safe for neuropsychiatric events compared with the first generation. The fatality rate due to first generation H1-AH associated neuropsychiatric events was higher than that of LTRA and ICS. More attention should be paid to specific patients treated with LTRA and H1-AH.

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Neuropsychiatric adverse drug reactions induced by montelukast impair the quality of life in children with asthma

Cited by 11 publications

References 24 publications

Adverse drug reactions affecting treatment adherence in first-line treatment of asthma: An observational study

Adverse drug reactions affecting treatment adherence in first-line treatment of asthma: An observational study

Increased Risk of Tourette Syndrome with Leukotriene Modifier Use in Children with Allergic Diseases and Asthma: A Nationwide Population-Based Study

Neuropsychiatric side reactions of leukotriene receptor antagonist, antihistamine, and inhaled corticosteroid: A real-world analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS)

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