Preschool children with high adherence to inhaled corticosteroids for asthma do not show behavioural problems

Quak, Wouter; Klok, Ted; Kaptein, Adrian A.; Duiverman, Eric J.; Brand, Paul

doi:10.1111/j.1651-2227.2012.02805.x

Cited by 11 publications

(7 citation statements)

References 29 publications

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“…Behavioural changes after inhaled corticosteroids have been reported before, although these seemed rare in some studies 24 25. Other studies in groups of children who studied the relationship between behaviour and inhaled corticosteroids did not show an association,26 even in young children with high adherence 27. This does not rule out that on an individual level children can exhibit different behaviour after inhaled corticosteroids due to individual vulnerability.…”

Section: Discussionmentioning

confidence: 88%

Psychiatric adverse drug reactions in the paediatric population

2020

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ObjectiveDue to lack of information on drug use in children, many drugs are used off-label in paediatrics. Increased knowledge of adverse drug reactions (ADRs) would enable a better risk–benefit analysis. Our aim was to characterise drugs causing psychiatric ADRs in children by conducting a descriptive study based on pharmacovigilance reports.DesignReports submitted to the Netherlands Pharmacovigilance Centre Lareb from 2003 to 2016 were used to investigate drugs causing psychiatric ADRs in the Dutch paediatric population. These data were corrected for drug utilisation in order to correct the number of reports for the number of users of a drug.Main outcome measuresORs were calculated as a measure of disproportionality for drug–ADR associations for three different age groups. Significant drug–ADR associations were checked if it was labelled in the product information.ResultsLareb received 918 reports of psychiatric ADRs, which constitute 15% of the reports of ADRs in children. Drugs used for the treatment of ADHD (methylphenidate and atomoxetine) and drugs used for the treatment of asthma (montelukast and fluticasone) were the most frequently reported. However, psychiatric ADRs were also reported for less often prescribed medications such as oxybutynin and isotretinoin.ConclusionsReal-world data on psychiatric ADRs in the Dutch paediatric population show a consistent pattern with what is known from drug labels and the literature. Reports of psychiatric ADRs should be taken seriously because of the impact on medication adherence and the well-being of the child and its family.

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Section: Discussionmentioning

confidence: 88%

Psychiatric adverse drug reactions in the paediatric population

2020

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“…Children initiated on ICS were less well controlled than those on montelukast; this group difference should have lessened the observed group difference, as asthma severity is usually associated with greater anxiety and depression [29,30]. Rescue or controller medications may cause neuropsychiatric ADRs, but the risk appears to be smaller than with montelukast [17,36]. Most ADRs occurred within the first 2 weeks, at a time of an expected reasonably good adherence.…”

Section: Limitationsmentioning

confidence: 99%

Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice

et al. 2017

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@ERSpublicationsThe incidence of children on montelukast with drug cessation due to neuropsychiatric adverse events was >10% http://ow.ly/nCGG30bgjpd ABSTRACT Although montelukast is generally well tolerated, postmarketing studies have reported serious neuropsychiatric adverse drug reactions (ADRs) leading to a United States Food and Drug Administration black box warning. The objective of this study was to determine the incidence of neuropsychiatric ADRs leading to discontinuation of montelukast in asthmatic children.We conducted a retrospective cohort study in children aged 1-17 years initiated on montelukast. In a nested cohort study, children initiated on montelukast as monotherapy or adjunct therapy to inhaled corticosteroids (ICS) were matched to those initiated on ICS monotherapy. A non-leading parental interview served to ascertain the occurrence of any ADRs with any asthma medication, and circumstances related to, and evolution of, the event.Out of the 106 participants who initiated montelukast, most were male (58%), Caucasian (62%) with a median (interquartile range) age of 5 (3-8) years. The incidence (95% CI) of drug cessation due to neuropsychiatric ADRs was 16 (10-26)%, mostly occurring within 2 weeks. Most frequent ADRs were irritability, aggressiveness and sleep disturbances. The relative risk of neuropsychiatric ADRs associated with montelukast versus ICS was 12 (2-90).In the real-life setting, asthmatic children initiated on montelukast experienced a notable risk of neuropsychiatric ADRs leading to drug cessation, that is significantly higher than that associated with ICS.

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“…Recent evidence suggests significant behavioural problems as a side-effect of montelukast in a small proportion of young children with wheeze [32]. This has also been described in case reports of children using ICS [33] but this side-effect appears to be very rare in preschool children [34]. Concerns remain, however, over the effects of ICS on height growth.…”

Section: Indications For and Choice Of Controller Therapymentioning

confidence: 96%

Classification and pharmacological treatment of preschool wheezing: changes since 2008

Brand

Caudri

Eber

et al. 2014

European Respiratory Journal

190

206

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Preschool children with high adherence to inhaled corticosteroids for asthma do not show behavioural problems

Abstract: Maintenance treatment with ICS, taken daily as prescribed, is not associated with an increased risk of behavioural problems in preschool children.

Cited by 11 publications

References 29 publications

Psychiatric adverse drug reactions in the paediatric population

Psychiatric adverse drug reactions in the paediatric population

Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice

Classification and pharmacological treatment of preschool wheezing: changes since 2008

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