E-drug: Re: Nimesulide and reasons for non-approval or withdrawal (cont)
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Dear Dr. Maqsood,
Due to multiple reports of serious adverse drug reactions, pediatric
nimesulide products have been suspended in Portugal as of April, 1999. Of
the 17 reactions reported, the most frequent were dermatologic and hepatic
in nature, including two cases of fatal Reyes syndrome. It is to be noted
that 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. Further risk/benefit
evaluation of pediatric nimesulide use is ongoing (Anon: SCRIP World
Pharmaceutical News. PJB Publications, Ltd., London; No 2431, April 23,
1999, p 20).
In Israel too, the drug has been banned for pediatric use. At the Drug
Information Helpline, I have maintained a complete file on the drug
through information on e-drug. I have read that in Sri Lanka, the Ministry
of Health did a lot of investigation about registering the drug and finally
decided not to.
I believe when more safer drugs as paracetamol are already available it is
irrational to prescribe me-too drugs of doubtful efficacy.
helpline <helpline@best.net.pk>
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