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Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences. Uppsala Monitoring Ctr, Res Sect, Uppsala, Sweden.
Uppsala Monitoring Ctr, Res Sect, Uppsala, Sweden.
Uppsala Monitoring Ctr, Res Sect, Uppsala, Sweden.
Univ Nottingham, Div Med Sci & Grad Entry Med, Derby, England.
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2019 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 28, no 5, p. 680-689Article in journal (Refereed) Published
Abstract [en]

Purpose: The purpose of this study is to uncover previously unrecognised risks of medicines in paediatric pharmacovigilance reports and thereby advance a safer use of medicines in paediatrics. Methods: Individual case safety reports (ICSRs) with ages less than 18 years were retrieved from VigiBase, the World Health Organization (WHO) global database of ICSRs, in September 2014. The reports were grouped according to the following age spans: 0 to 27 days; 28 days to 23 months; 2 to 11 years; and 12 to 17 years. vigiRank, a data-driven predictive model for emerging safety signals, was used to prioritise the list of drug events by age groups. The list was manually assessed, and potential signals were identified to undergo in-depth assessment to determine whether a signal should be communicated. Results: A total of 472 drug-event pairs by paediatric age groups were the subject of an initial manual assessment. Twenty-seven drug events from the two older age groups were classified as potential signals. An in-depth assessment resulted in eight signals, of which one concerned harm in connection with off-label use of dextromethorphan and another with accidental overdose of olanzapine by young children, and the remaining signals referred to potentially new causal associations for atomoxetine (two signals), temozolamide, deferasirox, levetiracetam, and desloratadine that could be relevant also for adults. Conclusions: Clinically relevant signals were uncovered in VigiBase by using vigiRank applied to paediatric age groups. Further refinement of the methodology is needed to identify signals in reports with ages under 2 years and to capture signals specific to the paediatric population as a risk group.

Place, publisher, year, edition, pages
WILEY , 2019. Vol. 28, no 5, p. 680-689
Keywords [en]
adverse drug reaction reporting systems, individual case safety reports, paediatrics, pharmacoepidemiology, pharmacovigilance
National Category
Public Health, Global Health, Social Medicine and Epidemiology Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-390043DOI: 10.1002/pds.4734ISI: 000472004500017PubMedID: 30767342OAI: oai:DiVA.org:uu-390043DiVA, id: diva2:1340376
Available from: 2019-08-05 Created: 2019-08-05 Last updated: 2019-08-05Bibliographically approved

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