ArticleInternational journal of clinical pharmacy2014
Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011.
Article in International journal of clinical pharmacy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.
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Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Neuropsychiatric events associated with montelukast in patients with asthma: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2023Pooled it
- A systematic review of adverse drug events associated with administration of common asthma medications in children.PloS one · 2017Pooled it
- Article
- Severe lactic acidosis and persistent diastolic hypotension following standard dose of intermittent nebulized salbutamol in a child: a case report.Journal of medical case reports · 2022Article
- Inhaled Drug Therapy-Associated Adverse Reactions in Obstructive Respiratory Diseases: A Review of a Decade of Reporting to the Portuguese Pharmacovigilance System.International journal of environmental research and public health · 2021Review
- Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports.Drug safety · 2020Article
- Transient symptomatic hyperglycaemia secondary to inhaled fluticasone propionate in a young child.BMC pulmonary medicine · 2016Article
Corrections and comments
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Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformation about safety issues from use of asthma medications in children is limited. Spontaneous adverse drug reaction (ADR) reports can provide information about serious and rarely occurring ADRs in children.
objectiveTo characterize paediatric ADRs reported for asthma medications licensed for paediatric use.
settingSpontaneous ADR reports located in the European ADR database, EudraVigilance.
methodADRs reported for asthma medications licensed for paediatric use from 2007 to 2011 were analysed. The included substances were beclometasone, budesonide, fenoterol, fluticasone, formoterol, mometasone, montelukast, salbutamol and terbutaline and the combinations of budesonide/formoterol, fenoterol/ipratropium and fluticasone/salmeterol.
main outcome measuresReported ADRs were categorized with respect to distribution on age, sex, type and seriousness of reported ADRs, medications and type of reporter. The unit of analysis was one ADR.
resultsWe located 326 spontaneous reports corresponding to 774 ADRs for the included asthma medications. Approximately 85% of reported ADRs were serious including six fatal cases. In total, 57% of ADRs were reported for boys. One quarter of all ADRs occurred in children up to 1 year of age. Physicians reported the majority of ADRs. Across medicines, the majority of reported ADRs were of the type "psychiatric disorders" (13% of total ADRs), followed by "respiratory, thoracic and mediastinal disorders" (10% of total ADRs) and "skin and subcutaneous disorders" (9% of total ADRs). The largest number of ADRs was reported for budesonide (21% of total ADRs), followed by salbutamol (20% of total ADRs) and fluticasone (19% of total ADRs). For salbutamol, the largest numbers of serious ADRs were "tachycardia", "accidental exposure/incorrect dose administered" and "respiratory failure".
conclusionOnly a few ADRs from use of asthma medications in children were identified in the EudraVigilance ADR database, but a large majority of these were serious including fatal cases.
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