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Anonymous writes "Case Report:
Although there might be several cases of NSAIDs induced hepatic damage in Aligarh and elsewhere that are not being reported, but we could find one definite case of Nimesulide induced hepatitis in Aligarh.
The 5-year-old male child, wt 22 Kg came to see a private paediatric consultant with a complaint of fever for the last 8 days on 28.2.2003. The history of present illness was elicited from patient’s attendant who says that his child was apparently well before 8 days when he developed fever, which was unrecorded, continuous and low grade initially and not, associated with chills and rigors. The fever has increased in intensity for the last 8 days (It is very hot to touch the patient now). The fever was not associated with vomiting, cough or yellow discoloration of urine or clay colored stool. The patient was seen by pediatricians and started prophylactic treatment for Paratyphoid as Ofloxacin (Syrup Zenflox Forte) 1-1/4 spoonful twice daily for 10 days, Syrup Corcef 100 mg twice daily and Nimesulide (Syrup Nimica 50) 1-1/4 spoonful (5 ml). On second day, Enzymes (Syrup Gastrium) for 6 weeks and Multivitamins + Iron (Elixir Nigoadine) 1-1/4 spoonful thrice daily were added.
Haemogram and widal test were done. On the same day of visiting, the widal came out to positive. Other examination showed pulse rate as 110 /min; respiratory rate – 18/min; temperature 1040 F; pallor – mild; no icterus; tongue coated. On systemic examination, chest bilaterally was clear, on per abdominal examination, no tenderness, spleen was palpable but no hepatomegaly was there. No abnormality was detected during CVS and CNS examination. Patient had no history of jaundice in past or history of blood transfusion or antitubercular treatment or any other drug as such. Family history showed no history of contact with jaundiced patient in family. Immunization status showed no history of receiving Hepatitis B Vaccines.
After 15 days of the above treatment i.e. on 15.3.2003, the patient felt weakness and on 18.3.2003, the patient was diagnosed as a case of jaundice on the basis of the following signs and symptoms. On general examination, icterus was present, the liver found to be three-fingers enlarged and firm, simultaneously the spleen was also palpable; other systems were normal on examination. Following investigation were advised and their outcome: S. Bilirubin - 8.70 mg/dl; SGOT/AST - 293 U/L; SGPT/ALT - 785 U/L and Alkaline Phosphatase - 22 KAU; Australia Antigen [Hbs Ag] and Malaria Parasite [ELISA] - negative. One week after dechallenge of the suspected drug nimesulide, LFT was again advised: S. Bilirubin – 0.8 mg/dl; SGOT/AST – 45 U/L; SGPT/ALT – 40 U/L and Alkaline Phosphatase - 16 KAU. Causal relationship could thus be made on the basis of temporal sequence and positive dechallenge.
Conclusion: Nimesulide, similar to other nonsteroidal anti-inflammatory drugs (NSAIDs), has been associated with rare and unpredictable but serious hepatic adverse reactions (2). Many studies showed that nimesulide causes the most frequent dermatological and hepatic side effects in nature, including fatal Reyes syndrome (3). Concomitant therapy with other drugs (amoxicillin/clavulanic acid, lysine salicylate) in many of these cases prohibits a definitive causal link of the adverse reaction to nimesulide therapy. Authors believe when more safer drugs as paracetamol are already available it is irrational to prescribe me-too drugs of doubtful efficacy. It is high time that Drug Control Authorities in India review their policy for granting permission to drugs and drug formulations. India has more than 65000 formulations approved by Drug Controller of India, which is highest for any country in the world.
Even if the Indian drug control agencies are reluctant to impose a total ban on nimesulide, they should immediately forbid its use for treatment of fever or pain. It will be unfortunate if the Indian government waits for another "committee" report before stopping the use of nimesulide, even for the treatment of pain or fever, and lets more innocent patients suffer needlessly. Remember, in September 2002, the Drugs Controller General of India, ordered a review of the drug in view of concerns of hepatotoxicity and the review committee came with the distrustful results. "
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Posted on Sunday, June 29 @ 03:01:19 GMT by mantra |
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Average Score: 5 Votes: 1

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