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Nimesulide Patients Still Exposed To A Risk of Severe Hepatitis
Nimesulide Patients Still Exposed To A Risk of Severe Hepatitis
a- Many sections of this document were blacked out, especially numerical data (ref 7).
b- Nimesulide was withdrawn from the market in Finland and Spain in 2002, and is no longer available in
Argentina, Belgium, Ireland and Singapore (ref 19).
c- Fourteen cases of severe liver damage were reported
among patients treated with nimesulide, representing a rate
of 29 cases per 100 000 patient-years, versus 15.6 cases per
100 000 with other NSAIDs (ref 11).
Adverse Effects
toxicity of nimesulide is unclear (15).
A hypersensitivity reaction has been
suggested (13). In addition, the presence
of a nitroaromatic nucleus means that
nimesulide is chemically similar to nitrofurantoin and tolcapone, both of which are
toxic to the liver (15-18).
Literature search
Our literature search was based on continuous prospective follow-up at the Prescrire
library, contents listings of the main international journals, Current Contents-Clinical Medicine, member bulletins of the International
Society of Drug Bulletins (ISDB), and systematic consultation of clinical pharmacology
textbooks (Martindale The Complete Drug Reference, Stockleys Drug Interactions). We also
accessed Medline (2007-August week 5, 2010),
Embase/Excerpta Medica Drugs and Pharmacology (2007-2010 3rd quarter), Reactions
(2007-September 2010) and The Cochrane
Library (Central, DARE, HTA, Nhseed; 2010
issue 6; and CDSR, 2010 issue 3).
1- Prescrire Rdaction Nimsulide et hpatites Rev
Prescrire 2002; 22 (228): 356.
2- Nimesulide. In: Martindale The Complete
Drug Reference The Pharmaceutical Press, London. www.medicinescomplete.com accessed
4 November 2010: 6 pages.
3- Prescrire Editorial Staff Nimesulide and hepatitis Prescrire Int 2008; 17 (93): 12.
4- Prescrire Rdaction Nimsulide: un anti-inflammatoire non strodien lorigine dhpatites
mortelles Rev Prescrire 2009; 29 (313): 824.
5- Andrade RJ et al. Fatal hepatitis associated with
nimesulide J Hepatol 2000; 32 (1): 174.
6- Prescrire Rdaction Nimsulide. Un antalgique
AINS sans intrt particulier Rev Prescrire 1998; 18
(183): 243-245.
7- EMEA - CHMP Co-rapporteur (Ireland) - Follow-up assessment report - EMEA/H/107/871 Nimesulide-containing medicinal products for systemic use 28 March 2008: 18 pages.
8- EMEA - CHMP Co-rapporteur (Ireland) - Assessment report - EMEA/H/107/871 Nimesulide-containing medicinal products for systemic use.
9- EMEA - CHMP Interim assessment report (following suspension in accordance with Article 107 of
Directive 2001/83/EC) - Nimesulide-containing medicinal products for systemic use 16 May 2007:
12 pages.
10- Page M et al. Hpatite fulminante lie un
traitement par nimsulide: encore un cas et revue
de la littrature Ann Fr Anesth Reanim 2008; 27:
742-746.
11- Traversa G et al. Cohort study of hepatotoxicity associated with nimesulide and other nonsteroidal anti-inflammatory drugs BMJ 2003; 327:
18-22.
12- Lee CH et al. Increased risk of hospitalization
for acute hepatitis in patients with previous exposure to NSAIDs Pharmacoepidemiol Drug Saf 2010;
19: 708-714.
13- Afssaps Nimesulide containing products
EMEA/H/107/871 Second list of questions. Prelim-