E-drug: Re: Nimesulide and reasons for non-approval or withdrawal
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Dear Dr. Mishra,
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 Pakistan, the drug is not registered for pediatric use. And In Israel
also, the drug has been banned. You will find a lot of material about it on
e-drug. Myself 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.
Regards
helpline <helpline@best.net.pk>
[You forgot your name and affiliation, but since you are a regular
contributor, I let it pass! KM, co-moderator]
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