Adverse drug reactions to nonsteroidal anti-inflammatory drugs, COX-2 inhibitors and paracetamol in a paediatric hospital.

AIMS: The use of nonsteroidal anti-inflammatory drugs (NSAIDs) in children has rapidly escalated over the last 5 years in Australia. This is primarily as a result of the availability of ibuprofen as an over-the-counter preparation. Several recent, significant adverse drug reactions (ADRs) to NSAIDs, at the Royal Children's Hospital (RCH) in Melbourne, Australia prompted review of all of the RCH reactions reported to these agents over 5 years.

METHODS: The ADR programme documents both spontaneously reported ADRs and ADRs identified by discharge coding. For this study, reported reactions to aspirin, celecoxib, ibuprofen, indomethacin, naproxen, paracetamol and rofecoxib, for the previous 5-year period, were retrieved from the hospital ADR database.

RESULTS: Nineteen reports of ADRs to NSAIDs and six to paracetamol, in patients aged from 4 months to 22 years (median 10 years) were identified. Reactions were predominantly rash (n = 10), gastrointestinal (n = 5) and respiratory (n = 4) side-effects. These included reports of haematemesis with both celecoxib and ibuprofen. One patient died of severe acute exacerbation of asthma following initiation of rofecoxib.

CONCLUSION: NSAID exposures are a significant cause of morbidity in children. Both nonselective NSAIDs and the newer COX-2 inhibitors were associated with significant drug reactions. The overall severity of these ADRs highlights the need for vigilant surveillance of ADRs in paediatrics, including both established and newer agents.