Adverse Drug Reactions (ADRs) of Montelukast in Children

Abstract

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.

Evaluation of Neuropsychiatric Effects of Montelukast–Levocetirizine Combination Therapy in Children with Asthma and Allergic Rhinitis

“…In another similar study in the literature, the most frequently observed neuropsychiatric effects after montelukast treatment were reported as irritability, aggressive behavior, and sleep disorders [ 24 ]. In a different study conducted in children in the literature, sleep problems and agitation were observed most frequently after the use of montelukast, similar to our study [ 35 ]. According to the literature and our study, the most common neuropsychiatric effects seen with the use of montelukast in children are similar.…”

Meta-analysis of the relationship between montelukast use and neuropsychiatric events in patients with allergic airway disease

“…In this study, we screened all NEs associated with montelukast and found that headache was the most common NE in all RCT studies, although our analysis did not reveal a relationship between NE and montelukast. In addition, the high incidence of such NEs among adults and children in the United States, Canada, and Europe [ 37 ] suggests that montelukast may lead to NEs. Consequently, montelukast-associated NEs have drawn much attention from practicing pediatricians in the United States, Australia, and the United Kingdom.…”

Is montelukast helpful in managing obstructive sleep apnoea in children with Down syndrome?

“…Issues with the safety profile of montelukast are well-documented; sleep disturbance, agitation and behavioural disturbance have been reported,11 but the prevalence of adverse effects varies widely in the literature (0%–31.9%)1 3 4 11; while the wide range of reported prevalence of adverse effects may be attributable to study design and follow-up, the indication, dose and duration of treatment, as well as the use of montelukast as a supplemental or primary treatment may also be of relevance. Systematic reviews of montelukast use in OSA have a paucity of information regarding its safety profile, although nausea and headaches have been reported 12.…”