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Prospective observational study of adverse drug reactions to diclofenac in children
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. (Farmakometri)
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2009 (English)In: British Journal of Clinical Pharmacology, ISSN 0306-5251, E-ISSN 1365-2125, Vol. 68, no 2, 243-251 p.Article in journal (Refereed) Published
Abstract [en]

center dot Diclofenac is frequently used off-label in children for acute pain, but little information is available on diclofenac adverse   drug reactions in this population.   WHAT THIS STUDY ADDS   center dot The common adverse drug reactions of diclofenac for acute   pain in children are of a similar type to those seen in adults. center dot Serious adverse reactions occur in < 0.8% of children and   the incidence of diclofenac-induced bronchospasm in asthmatic children   is < 2.7%.   AIM  The aim of this study was to investigate the type of common (occurring   in > 1% of patients) adverse reactions caused by diclofenac when given   to children for acute pain.   METHODS   A prospective observational study was undertaken on paediatric surgical   patents aged < 12 years at Great Ormond Street and University College   London Hospitals. All adverse events were recorded, and causality   assessment used to judge the likelihood of them being due to   diclofenac. Prospective recruitment meant not all patients were   prescribed diclofenac, allowing an analysis of utilization. Causality   of all serious adverse events was reviewed by an expert panel.   RESULTS   Children prescribed diclofenac were significantly older, and stayed in   hospital for shorter periods than those who were not. Diclofenac was   not avoided in asthmatic patients. Data on 380 children showed they   suffer similar types of nonserious adverse reactions to adults. The   incidence (95% confidence interval) of rash was 0.8% (0.016, 2.3);   minor central nervous system disturbance 0.5% (0.06, 1.9); rectal   irritation with suppositories 0.3% (0.009, 1.9); and diarrhoea 0.3%   (0.007, 1.5). No serious adverse event was judged to be caused by   diclofenac, meaning the incidence of serious adverse reactions to   diclofenac in children is < 0.8%.   CONCLUSION   Children given diclofenac for acute pain appeared to suffer similar   types of adverse reactions to adults; the incidence of serious adverse   reaction is < 0.8%.

Place, publisher, year, edition, pages
2009. Vol. 68, no 2, 243-251 p.
Keyword [en]
acute pain, adverse drug reaction, children, diclofenac, drug utilization
National Category
Pharmaceutical Sciences
URN: urn:nbn:se:uu:diva-122397DOI: 10.1111/j.1365-2125.2009.03447.xISI: 000268789700014PubMedID: 19694745OAI: oai:DiVA.org:uu-122397DiVA: diva2:309988
Available from: 2010-04-12 Created: 2010-04-12 Last updated: 2010-07-12Bibliographically approved

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