• child health
• drug-related side effects and adverse reactions
• gastrointestinal diseases
• pediatrics
• 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.