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- child health
- drug-related side effects and adverse reactions
- gastrointestinal diseases
- adolescent medicine
High doses or prolonged use of diclofenac, a commonly prescribed non-steroidal anti-inflammatory drug (NSAID), may result in gastrointestinal complications, which, if ignored, can be fatal. A preventable death attributed to diclofenac in a 16-year-old girl with complex needs has been identified, and is described in this article. Adverse drug reactions from NSAIDs should be considered and treated in children and adolescents, especially those with complex needs.
This article is part of the Coroners’ Concerns to Prevent Harms series.1 It discusses a Prevention of Future Death (PFD) report related to harm from diclofenac in an adolescent.2
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) that is commonly prescribed for its analgesic, antipyretic and anti-inflammatory effects. About 658 000 prescriptions were dispensed for diclofenac in English primary care in the 12 months from September 2019 to August 2020, costing £8.3 million.3 Diclofenac is thought to exert its action by reducing prostaglandin synthesis through inhibition of the cyclo-oxygenase enzymes (COX-1 and COX-2). It is classified as a non-selective COX inhibitor, though in vitro studies have shown it preferentially inhibits COX-2 more than COX-1.4
Diclofenac is most commonly prescribed for pain relief but the specific indications for its use in children and adolescents vary by age, as recommended in the British National Formulary for Children, see box 1.5 Diclofenac, along with other NSAIDs, is associated with increased risks of bleeding, cardiovascular events, renal impairment and gastrointestinal complications, including peptic ulcer disease.6 These harms are well reported in the elderly, and NSAIDs have been implicated in 30% of all hospital admissions due to preventable adverse drug reactions (ADRs).7 However, the prevalence of such harms is not well studied in children and adolescents.
EBM facts: Information on diclofenac from the British National Formulary for Children
Tablet (immediate and modified release);
Eye drops; and
Indications for use
Inhibition of intraoperative …
Twitter @_ETThomas, @Richards_G_C
Contributors ETT devised the idea for this article, identified the coroner’s report and wrote the first draft of the manuscript. GCR also devised the idea for this article, analysed and presented the data on reports to the Medicines and Healthcare products Regulatory Agency Yellow Card Scheme, and contributed to drafting and editing the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests ETT is financially supported by a University of Oxford Clarendon Scholarship to study for the degree of Doctor of Philosophy (DPhil/PhD). GCR is financially supported by the National Institute of Health Research (NIHR) School for Primary Care Research, the Naji Foundation and the Rotary Foundation to study for the degree of Doctor of Philosophy (DPhil/PhD). GCR is an editorial registrar of BMJ Evidence Based Medicine and is developing the https://preventabledeathstracker.net/ website. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care.
Provenance and peer review Not commissioned; internally peer reviewed.