Two drug categories are mainly used worldwide to reduce the discomfort related to febrile illnesses and alleviate moderate pain in children: acetaminophen and NSAID (non-steroidal anti-inflammatory drug), mainly ibuprofen. These two clinical conditions are benign and the discomfort is moderate, so the safety profile of these drugs needs to be very good and has been the source of a lengthy, on-going debate. This debate has mainly focused on the safety profile of ibuprofen that on pain and febrile illnesses by inhibiting cyclooxygenase 1 and 2. This mechanism of action explains the main safety concerns, which are for the risk of renal failure, gastrointestinal bleeding and severe bacterial infection. Clinical data supporting the safety of ibuprofen are dominated by the reassuring results of a large randomised double-blind trial (n = 84,192) published in 1995 that compared the safety of ibuprofen to acetaminophen in febrile children. The results of this large trial contributed to the over-the-counter (OTC) status later granted to the drug obtained later. Since that study was published, several observational studies have shown a strong and significant association between ibuprofen exposure and rare but serious adverse events. These events included upper gastrointestinal bleeding, acute renal failure, notably during gastroenteritis, severe bacterial infections, including soft-tissue necrotising fasciitis during varicella, pleural empyema and loco-regional complications of pharyngitis. NSAIDs have retained their OTC status because the risk and benefit ratio was still considered favourable. However, NSAIDs are no longer recommended and, or, are contraindicated by several national health agencies and medical societies for two clinical situations considered with a medium to high risk of complications: dehydration and varicella.
The studies that are available show an important variability in NSAID use by parents and physicians. For the management of febrile illnesses, rate of use varies from 15% in France and Canada, to 80% in the United States and Australia. Recent research have also shown a differential use of NSAID in children by parents and physicians, the last ones being more likely to avoid its prescription in at risk situations (varicella, dehydration). These variations in the use NSAIDs in children suggest that in one hand some children to not benefit of a safe drug in some countries, or, on the other hand, that some children are overexposed to the rare but serious risk of NSAID adverse effects during benign episodes of discomfort related to febrile illnesses and moderate pain.
The objectives of the present research topic are to highlight the importance of the debate on NSAID safety profile and risk-benefit balance in the pediatric population by catalyzing the publication of new clinical findings but also of position papers regarding:
- The extent of the use of NSAID in children;
- The safety profile of NSAID in children, with a special interest on acute kidney injuries, gastrointestinal bleeding and severe bacterial infection notably empyema,
- The risk-benefit ratio of NSAID for its main indications in pediatrics.
These articles will help useful to guide clinical, public health and parental decisions.
Two drug categories are mainly used worldwide to reduce the discomfort related to febrile illnesses and alleviate moderate pain in children: acetaminophen and NSAID (non-steroidal anti-inflammatory drug), mainly ibuprofen. These two clinical conditions are benign and the discomfort is moderate, so the safety profile of these drugs needs to be very good and has been the source of a lengthy, on-going debate. This debate has mainly focused on the safety profile of ibuprofen that on pain and febrile illnesses by inhibiting cyclooxygenase 1 and 2. This mechanism of action explains the main safety concerns, which are for the risk of renal failure, gastrointestinal bleeding and severe bacterial infection. Clinical data supporting the safety of ibuprofen are dominated by the reassuring results of a large randomised double-blind trial (n = 84,192) published in 1995 that compared the safety of ibuprofen to acetaminophen in febrile children. The results of this large trial contributed to the over-the-counter (OTC) status later granted to the drug obtained later. Since that study was published, several observational studies have shown a strong and significant association between ibuprofen exposure and rare but serious adverse events. These events included upper gastrointestinal bleeding, acute renal failure, notably during gastroenteritis, severe bacterial infections, including soft-tissue necrotising fasciitis during varicella, pleural empyema and loco-regional complications of pharyngitis. NSAIDs have retained their OTC status because the risk and benefit ratio was still considered favourable. However, NSAIDs are no longer recommended and, or, are contraindicated by several national health agencies and medical societies for two clinical situations considered with a medium to high risk of complications: dehydration and varicella.
The studies that are available show an important variability in NSAID use by parents and physicians. For the management of febrile illnesses, rate of use varies from 15% in France and Canada, to 80% in the United States and Australia. Recent research have also shown a differential use of NSAID in children by parents and physicians, the last ones being more likely to avoid its prescription in at risk situations (varicella, dehydration). These variations in the use NSAIDs in children suggest that in one hand some children to not benefit of a safe drug in some countries, or, on the other hand, that some children are overexposed to the rare but serious risk of NSAID adverse effects during benign episodes of discomfort related to febrile illnesses and moderate pain.
The objectives of the present research topic are to highlight the importance of the debate on NSAID safety profile and risk-benefit balance in the pediatric population by catalyzing the publication of new clinical findings but also of position papers regarding:
- The extent of the use of NSAID in children;
- The safety profile of NSAID in children, with a special interest on acute kidney injuries, gastrointestinal bleeding and severe bacterial infection notably empyema,
- The risk-benefit ratio of NSAID for its main indications in pediatrics.
These articles will help useful to guide clinical, public health and parental decisions.
