Adverse drug reactions to NSAIDs

Abstract

Whilst the debate on the safety of selective COX-2 inhibitors continues, articles such as the paper presented by Titchen et al. [1] do little to allay public fears about NSAIDs in general. This hospital based study of adverse drug reactions (ADRs) was effectively a retrospective audit of reactions suffered by children attending one paediatric facility in Australia. The authors’ conclusion that NSAIDs as a class are a significant cause of morbidity in children is without foundation. Firstly, no data are given about numbers of children who received NSAIDs without adverse effect. Secondly, from their data, 19/754 children suffered a probable or possible ADR to NSAIDs (2.5%). Of these, only 10/754 (1.3%) children had an ADR to ibuprofen alone. In comparison, the paracetamol ADR was 0.8%, which given the small sample size is in my view a comparable figure. Interestingly, of the 10 children who had a reaction to ibuprofen, haematemesis occurred in three cases, all in adolescents taking between 1600 and 1800 mg day−1 of the drug. This dose is in excess of UK recommendations for this age group, where the dose for juvenile rheumatoid arthritis is a maximum of 15 mg kg−1, so that even a 70 kg teenager would not receive a dose greater than 1050 mg under normal circumstances. Finally, the authors report one tragic case of a death with respiratory complications in a 10 year old girl on one tablet a day rofecoxib, and in whom the likelihood of an ADR was probable (Naranjo scale). Whilst I agree with the authors that we should develop better guidelines and carry out vigilant surveillance of ADRs in the paediatric population there is a risk that data such as those presented in this study could be misinterpreted by the media, the lay press and the public at large, causing further confusion and anxiety.