Case Study: Evidence of first nimesulide-induced hepato-renal toxicity in an Indian child

Summary

This is the first evidence of nimesulide toxicity in an Indian child as reported by Dr. Gaurav Gupta, working in collaboration with the National Institute of Pharmaceutical Education and Research (NIPER) in Mohali.

A 6-year-old male child had a fever for four days and had received nimesulide (without prescription) for those four days, before seeing a doctor. Upon examination, the patient was found to have jaundice and haematuria. The laboratory investigations indicated that the most probable cause for jaundice and haematuria was nimesulide, since serological tests were negative.

This work will help the decision-making bodies to make appropriate decision(s) regarding the use of nimesulide in adult and geriatric patients as well.

Background

Nimesulide is a preferential cyclooxygenase-2 (COX-2) inhibitor. It is preferable over other NSAIDs, as it causes fewer gastrointestinal side effects.^1,2 Nimesulide may cause a wide spectrum of liver injury, from asymptomatic increase in liver enzymes to jaundice and even death due to liver failure, although this is rare. ^3-11 Children receiving nimesulide are more prone to hepatotoxicity.¹² Nimesulide-induced renal toxicity can be due either to the severity of the liver disease or possibly to NSAID-induced interference with vasodilatory prostaglandins, causing unopposed renal arteriolar constriction. This can cause an increase in the creatinine, blood urea nitrogen (BUN), presence of RBCs, albumin and bile salt in urine.¹³

Due to its known adverse effect profile, nimesulide has been banned for paediatric use below the age of 12 by the DCG(I).¹⁴ It is also suggested that nimesulide may be associated with jaundice and haematuria even in therapeutic doses.

Case Presentation

A 6-year-old male child presented with a fever that he had for four days, and he had received nimesulide (without prescription) for those four days, before seeing a doctor. Upon examination, the patient was found to have jaundice and haematuria. The liver function test (LFT), complete blood count, urine examination and serological test were performed to assess the situation.
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