[e-drug] Nimesulide status

e-drug
1

E-DRUG: Nimesulide status
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Dear E-druggers,

I would like to know about the status of Nimesulide post the reported
episodes of hepatotoxicity leading to some fatal conditions. I read that even though the marketing rights are still in place, the use is going
to be a restricted and highly monitored.

The problem with the third world is that even the normal medications/routine
medications can not be kept under check /balance and /or monitoring, let
alone a notorious and not so effective drug as nimesulide. Reasons for this
are manifold, from issues relating to regulatory check deficiences to
inability of spreading the information over a wide range of end users.
Would it not be a wise decision to ban the use of the drug /marketing of the
drug in countries like ours? where a check on use and misuse can not be
practically possible?

Any comments, and any relevant websites about the current status and why it
should be banned/ discontinu marketing in our part of the world will be
highly appreciated.

Regards,

Ozma Fazal
Staff Pharmacist
Aga Khan Hospital
Karachi, Pakistan
E-mail: ozma.fazal@gmail.com

2

E-DRUG: Nimesulide status (2)
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Dear E-druggers,

Nimesulide has been associated with acute liver toxicity, resulting
in a first referral to the European Committee for Medicinal Products
for Human Use (CHMP) by Finland in 2001-2003, and the second by
Ireland in 2007. In both cases the CHMP has examined the hepatic
risk of nimesulide and twice has concluded that on the evidence
provided, the overall risk-benefit ratio of nimesulide is not worse
than with other NSAIDs. Risk-reducing measures such as recommending
using it short-term (less than 15 days) are being implemented.

It is not certain that removing the drug from the market would
significantly reduce the population risk related to the use of
NSAIDs or other drugs used in the same indications.

Best regards,

S. Ezgi Gulmez MD, PhD
Département de Pharmacologie
CHU de Bordeaux - Université Victor Segalen
Bâtiment du Tondu
Case 41
146, Rue Léo Saignat
33076 Bordeaux Cedex, France
Tel : +33 55757 4675
Fax: +33 55757 4740
E-mail: sinemezgi.gulmez@u-bordeaux2.fr
http://www.pharmacoepi.eu

Pr Nicholas Moore, MD, PhD, FRCP (Edin), FISPE
Professeur de Pharmacologie Clinique
Chef de Service
Département de Pharmacologie
CHU de Bordeaux - Université Victor Segalen - INSERM
U657
Case 36
146, Rue Léo Saignat
33076 Bordeaux Cedex, France
Tel: +33 55757 1560 - 4673 (after sec hours)
Fax: +33 55757 4671
E-mail: nicholas.moore@pharmaco.u-bordeaux2.fr
http://www.pharmacoepi.eu