[Focus on the safety of ibuprofen at the analgesic-antipyretic dose].

Abstract

Ibuprofen is a non-steroidal anti-inflammatory drug, available over the counter in most countries at analysis doses (600-1200 mg/day). After several years of such use, it would seem worthwhile to review recent safety data for this drug compared to reference analgesics. Spontaneous reporting to drug surveillance systems suggests one adverse reaction for every 5 million (UK) to 25 million (USA) 200 mg tablets sold, with one reported fatality for 0.6 to 23 billion tablets sold. During clinical and post-marketing studies, the frequency of adverse events was similar to that found with placebo or paracetamol. In a meta-analysis involving 46000 patients, the incidence of digestive events was 5 per cent, with 0.02 per cent upper GI bleeds. A prospective trial in 84000 children reported 0.007 per cent GI bleeds. Case-control studies of upper GI bleeding found odds ratios of the association with ibuprofen between 1 and 3, lower than those associated with aspirin, even at the low 'cardiovascular' doses. Other risks, such as the risk of renal failure, appear equally low. In the case of voluntary overdose, there appear to be little renal or other risk for ingested quantities below 6 g (30 tablets). Less than 1 per cent of the intoxications are rated as severe, and there have been even fewer fatalities. The favourable safety profile of ibuprofen may be related to short term use of low doses in otherwise healthy young patients, associated to a short product half-life, and may be to specific product properties. The quality of patient information may also be an important safety factor. When the safety of the drug in overdose is considered, substitution of aspirin or paracetamol, by ibuprofen, may actually reduce overall risk for the population.