NIMESULIDE (AULIN, MESULID, MESINE) SUSPENDED

WITH IMMEDIATE EFFECT

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Malcomson Law has learned that the Irish Medicines Board (IMB) has suspended the marketing
of medicines containing Nimesulide with immediate effect. Nemesuline is sold under the
brand names Aulin, Mesulid and Mesine.

Nimesulide is an anti-imflammatory drug known as a Cox-2 inhibitor, similar to Vioxx, which was
withdrawn from the world market in 2004 as it was found to cause potentially fatal side effects.
Malcomson Law is currently taking legal action on behalf of clients in the United States
and Ireland against Merck Pharmaceuticals, the manufacturer of Vioxx. We have also received
a number of enquiries from persons who have concerns regarding Nimesulide.
Nimesulide became available for sale on the Irish market in 1995. However, concerns regarding
this drug have been documented as early as 1999 when the Irish Medicines Board reported its
concerns to the World Health Organisation that patients were experiencing adverse side effects of
the drug, up to and including hepatic (liver) failure.
At this time, the IMB stated that it was awaiting the outcome of a Cohort Study on Hepatotoxicity
associated with Nimesulide and other Non-Steroidal Anti-Inflammatory drugs (NSAIDS), i.e., a
study into the potential hepatic (Liver) consequences of the drug. The results of this study
have been available since 2003 and the study indicated the following:
 Nimesulide increases the risk of adverse hepatic consequences by 30% in patients
with NO HISTORY of liver or renal problems
 Nimesulide increases the risk of adverse hepatic consequences by 90% in patients
who have a history of liver or renal problems
Similar reports indicating Nimesulide's potential hepatic consequences were published in 1999 by
the Lancet medical journal and by the Annuals of Pharmacotherapy in 2002.
Subsequent to the publishing of these findings, Nimesulide was withdrawn from the market in the
following countries:
1.Spain
2.Turkey
3.Finland
4.Japan
5.USA - the application was withdrawn. Nimesulide was NEVER made available on the
market
6.Australia - the application was withdrawn. Nimesulide was NEVER made available on
the market
7.UK - the application was withdrawn. Nimesulide was NEVER made available on the
market
8.Israel
9.Sri Lanka
10. India
Medical literature to date indicates that there have also been a significant number of reports of
adverse side effects of the drug:
 Belgium has reported 83 cases
 Italy has reported 225 cases
 Switzerland has reported 33 cases
In New Dehli, India, criminal charges have been filed against the Pharmaceutical company
responsible for Nimesulide because there were no warnings indicated on the drug relating to its
potential adverse effects on children under 12.
Until its withdrawal on 15 May 2007 in Ireland, the Irish Medicines Board imposed only a
contra-indication (which is in effect GP/Pharmacist guidance) regarding prescribing Nimesulide to
children under the age of 12.