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ADC Fetal and Neonatal Edition Letters and ADC Education and Practice Letters
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Estimation of risk requires a denominator
- David M Reith (5 March 2004)
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Ibuprofen and acute renal failure
- Dipak Kanabar (25 March 2004)
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David M Reith, Paediatric Clinical Pharmacologist University of Otago
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david.reith{at}stonebow.otago.ac.nz David M Reith
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Dear Editor Although it is reasonable to highlight an adverse event associated with a drug, it is also important to attempt to estimate the risk for the adverse event. The best estimate of risk associated with a treatment would come from a large randomised controlled trial. The Boston University Fever Study compared paracetamol (12 mg/kg) with ibuprofen (5 or 10 mg/kg) in 27,065 children under the age of two years.[1] A total of 17,938 children were treated with ibuprofen. No children were hospitalised with acute renal failure. The relative risk (95% CI) of hospitalisation for any reason in the four weeks following enrolment in the study in the ibuprofen group compared with the paracetamol group was 1.1 (0.9 to 1.3). I am not convinced of the merits of publishing single case reports, but if they are going to be published then a complete literature search should be performed. Reference (1) Lesko SM, Mitchell AA. The safety of acetaminophen and ibuprofen among children younger than two years old. Pediatrics. 1999 Oct;104(4):e39 |
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Dipak Kanabar, Consultant Dept. of Paediatrics, Guy' s Hospital
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Dipak.Kanabar{at}gstt.sthames.nhs.uk Dipak Kanabar
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Dear Editor In our modern era of evidence based practice, I was disappointed to see that the discussion of this case took no account of the weight of evidence that is widely published against its final conclusion i.e. that ibuprofen was the root cause of acute renal failure in their case. Whilst case reports are an interesting way of learning about new diseases or reporting new findings, it was, in my opinion, unsafe and unfair of the authors of this paper to have ingnored the largest ibuprofen monitoring study carried out by Lesko et al in 1999 of over 84 192 febrile children who received paracetamol or ibuprofen for fever management. Acute renal failure was reported in none of the cases of the ibuprofen arm of the trial (17938 children). Furthermore, in the case described by the authors, the possibility that their patient suffered acute renal failure due to dehydration alone was not entertained at all, and although they describe a state of mild dehydration, no indication is given of extent, nor is the state of sodium flux (serum sodium, urinary sodium and fractional excretion of sodium) indicated. Certainly their renal biopsy findings could be compatible with either diagnosis. I look forward to an interesting debate. Financial interests declared: The author has received financial emoluments from Boots Healthcare International and Crookes Healthcare in the past. |
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