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Why is Nimesulide banned in many countries?

Q: Is Nimesulide a banned drug in many countries?

A:Nimesulide is an NSAID that is being used as an anti-pyretic in children on a vast scale in India. Since it has not been approved by any English-speaking country (US, Britain, Canada, Australia etc) with good adverse reaction reporting system, there is not much data on Phase IV i.e. post-marketing experience. WHO has reported two deaths in children due to Reyes syndrome (WHO Newsletter 1999:2). As you know this a serious event resulting in death and debilitating liver and/or brain damage. Aspirin in children is implicated in similar adverse effect; that is why it is contraindicated in children below 12 years. In addition, fever, like cough and diarrhoea, is a protective mechanism. There is general agreement that fever should not be excessively brought down in children because the real cause may be ignored (for instance pneumonia, meningitis etc). There have been several articles in the British medical media warning doctors not to succumb to parental pressure to reduce fever below 40-41 degree C (about 101F). Nimesulide does exactly the same. So apart from its adverse effects on liver and possibility of Reyes syndrome, it is not an appropriate anti-pyretic because of its rapid effect - in fact too rapid to be good for children. It is definitely implicated in hepatotoxcity in therapeutic dose. Due to this reason its use has been prohibited in Finland, Spain and Turkey not only in children but adults too. In Finland one death and several cases of hepatic damage necessiating liver transplant have been reported. Currently the European Drug Evaluation Agency is reviewing its status for an all-European approach. In the next issue of MIMS, we will carry a detailed editorial on nimesulide.


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