Leukotriene receptor antagonists and risk of neuropsychiatric events in children, adolescents and young adults: a self-controlled case series

Park, Ji S.; Cho, Yoo Jung; Yun, Je-Yeon; Lee, Hye Jin; Yu, Jinho; Yang, Hyeon‐Jong; Suh, Dong In

doi:10.1183/13993003.02467-2021

Cited by 13 publications

(11 citation statements)

References 36 publications

(33 reference statements)

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“…This study reported a high prevalence of adverse drug reactions among 123 patients (31.9%), sleep disturbance was the most common (ADRs). Since 2008, there has been an increasing number of reports on potential adverse drug reactions to montelukast, including irritability, aggressiveness, and sleep disturbances, usually occurring after 1 week of commencing therapy and occurring in up to 10% of children [ 3 , 4 , 52 , 53 , 54 , 55 , 56 , 57 , 58 ]. The World Health Organization (WHO) pharmacovigilance database reported multiple adverse effects, including depression, headache, aggression, suicidal ideation, anxiety, insomnia, abnormal behavior, nightmares, shortness of breath, abdominal pain, nausea, rash, dizziness, myalgia and muscle spasm [ 53 ].…”

Section: Discussionmentioning

confidence: 99%

Adverse Drug Reactions (ADRs) of Montelukast in Children

et al. 2022

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Montelukast is a leukotriene receptor antagonist (LTRA) commonly prescribed for asthma, allergic rhinitis and sleep-related breathing disorders. Recently, some studies have reported several adverse events, such as neuropsychiatric disorders and sleep disturbances, among children. Objective: To obtain more insight into the safety profile of montelukast for children with asthma, allergic rhinitis and sleep-related breathing disorders. Method and results: We retrospectively studied all adverse drug reactions to montelukast among 385 children 6 months or older in six tertiary centers over a two-year period. A total of 89.6% were asthmatic, 50% had allergic rhinitis and 13.6% had sleep-related breathing disorders; Singulair was the most common type of montelukast used (67.9%). This study reported a high prevalence of adverse drug reactions among 123 patients (31.9%), predominantly in those aged 4–9 years (52.8%), followed by adolescents (24.4%) and toddlers (22.8%). Two (ADRs) were reported in 9.8% of the children, while three or more were reported in 5.5%. Sleep disturbance was the most common (ADRs), affecting 15.1% of participants (overlap was common; 5.5% of children experienced sleep difficulties, 4.4% experienced sleep interruption and decreased sleep, and 1.82% experienced nightmares), followed by agitation (10.4%), pain (9.4%) and hyperactivity (6.8%). No serious (ADRs) were reported. Eleven percent of families faced difficulties in purchasing montelukast, and only 57% of families had insurance. Misconceptions were common (9.8% reported it to be a steroid, while 30.6% believed it to be a bronchodilator). Although 81% of the families believed it was an effective and preventive medication, 5.3% stopped the drug due to concern about side effects, especially agitation (3%) and nightmares (0.6%). Conclusion: These data demonstrate that montelukast is effective, but the associated adverse neuropsychiatric drug reactions are more prevalent than those reported in the literature. In particular, sleep disturbance, agitation, pain and hyperactivity were observed. Pediatricians should be aware of such (ADRs). Misconceptions about montelukast are still common, and parental counseling and urgent epidemiological studies are needed to quantify the risk for management plans.

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Section: Discussionmentioning

confidence: 99%

Adverse Drug Reactions (ADRs) of Montelukast in Children

et al. 2022

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“…However, the postmarketing surveillance has observed that montelukast may induce adverse neuropsychiatric events (NPEs) and nightmares [33 ▪ ,34]. The risks of NPEs following LTRAs use vary over time (increasing in 4–7 days and 8–14 days after initiation of LTRA) and ages (increasing in adolescents and young adults but decreasing in children) [33 ▪ ]. In most cases, the nightmares disappear upon drug withdrawal, but in some cases, it takes a long time until the nightmares diminish [34].…”

Section: Pharmacotherapymentioning

confidence: 99%

“…Clinical trials (35 RCTs in adults and 11 in children) have revealed that the incidence of montelukast-induced adverse events is 2.73%, which is comparable with that of placebo [32]. However, the postmarketing surveillance has observed that montelukast may induce adverse neuropsychiatric events (NPEs) and nightmares [33 ▪ ,34]. The risks of NPEs following LTRAs use vary over time (increasing in 4–7 days and 8–14 days after initiation of LTRA) and ages (increasing in adolescents and young adults but decreasing in children) [33 ▪ ].…”

Section: Pharmacotherapymentioning

confidence: 99%

Highlights of the treatment of allergic rhinitis according to Chinese guidelines

Zhang

Cheng

2023

Current Opinion in Allergy &Amp; Clinical Immunology

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Purpose of review This review aimed to introduce the pharmacotherapy of allergic rhinitis according to the 2022 updated Chinese guidelines. Recent findings Despite recent advances in basic and clinical research worldwide, pharmacotherapy remains a mainstream in allergic rhinitis treatment. Usually, the first-line drugs, involving intranasal corticosteroids, second-generation oral and intranasal H1-antihistamines, or leukotriene receptor antagonists, can achieve acceptable outcomes in the treatment of allergic rhinitis. The second-line drugs, such as oral corticosteroids, intranasal decongestants and intranasal anticholinergics, can assist in controlling severe symptoms, like nasal congestion/blockage and watery rhinorrhea. For those with moderate-to-severe allergic rhinitis, evidence-based stepwise strategies are suitable, in which the types and dosages of drugs are de-escalated or upgraded according to their therapeutic efficacy. Meanwhile, omalizumab, a novel biological agent, has burgeoned to satisfy the need of patients. Summary This review highlights the staples in Chinese guidelines about the pharmacotherapy for allergic rhinitis to better understand the guidelines and promote the clinical practice.

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“…2 However, evidence regarding the risk of NEs associated with LTRAs has been conflicting. [3][4][5] To the best of our knowledge, no previous studies have reported the association of exposure to LTRAs during pregnancy with the risk of NEs in offspring. The present cohort study aimed to address this research question.…”

Section: Introductionmentioning

confidence: 98%

“…Over the years, the US Food and Drug Administration has monitored postmarketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious NEs associated with montelukast use in 2020 . However, evidence regarding the risk of NEs associated with LTRAs has been conflicting . To the best of our knowledge, no previous studies have reported the association of exposure to LTRAs during pregnancy with the risk of NEs in offspring.…”

Section: Introductionmentioning

confidence: 99%