Authors’ response

Abstract

We would like to thank Dr Kanabar for his letter and the points he raises. Dr Kanabar is correct in describing this study as a retrospective audit in one Australian paediatric hospital, albeit, a large centre that services a population of over 5 million. It is important to note that the adverse drug reactions (ADRs) described were all spontaneously reported. As spontaneous reporting schemes are able to detect only a small portion of the total ADRs that take place, many more ADRs were likely to have occurred but were not reported [1]. ADR reporting programs are an essential tool for detection of previously unrecognized side-effects, particularly in children where fewer studies have been undertaken. This study was not able to determine the number of children who received nonsteroidal anti-inflammatory drugs (NSAIDs) without adverse effect. The population included hospital inpatients, outpatients and children treated in the community who presented to the hospital. It is known, however, that the use of NSAIDs within the hospital has escalated in recent years [2]. We also know that the usage of paracetamol at The Royal Children's Hospital is many times greater than the use of NSAIDs [2], yet the total number of ADRs detected for NSAIDs was higher and more serious that those related to paracetamol. Furthermore, most of the ADRs reported to NSAIDs have been previously described in adults. The risk of ADRs is increased at increased dose, this dose–response effect supporting a causal relationship. As paracetamol and ibuprofen are currently available over the counter (OTC) in Australia, there may be a perception of relative safety and a greater potential for the use of higher than recommended dosing. Dr Kanabar's point about some high doses of NSAIDs found in our study is important and we agree that there is potential harm associated with high dosing of these OTC medications. Initiatives such as a ‘Box Warning’ and the limitation of OTC sales to pharmacies only would overcome some of these concerns. The target audience for this paper was not the media, lay press or public at large; it was paediatricians and clinical pharmacists involved in the management of children. It is acknowledged that there has been interest from the media in Australia and New Zealand in this paper, along with interest in other publications associating NSAID use with breast cancer and ischaemic heart disease. In Australia there has been recent substantial marketing of NSAIDs as OTC analgesics for the paediatric population. This may be one factor that has contributed to the increase in use noted at the Royal Children's Hospital. The authors have taken the opportunity of responding to media interest and interviews to emphasize the care required with use of all drugs in paediatrics and to stress that paracetamol is the recommended first line treatment for analgesia in paediatrics.