Abstract

• Nimesulide, a nonsteroidal anti-inflammatory drug (NSAID) that has been marketed in France since 1998, is neither more effective nor better tolerated than other NSAIDs.
   
• Many reports and reviews published by drug regulatory agencies in Spain, Ireland and Italy have warned of the hepatic adverse effects of nimesulide. In early 2008, 17 cases of nimesulide-induced liver damage requiring transplantation had been reported in Ireland, Italy, Spain, Finland and France.
   
• An Italian retrospective study conducted between 1997 and 2001, including about 400 000 patients exposed to NSAIDs, showed that the risk of severe liver damage was twice as high with nimesulide as with other NSAIDs.
   
• The European pharmacovigilance database shows that nimesulide is associated with more cases of severe liver damage than other NSAIDs, as well as more cases of liver damage than with cox-2 inhibitors.
   
• Young women are particularly at risk. In the vast majority of cases of liver damage, the dose of nimesulide used was that recommended in the summary of product characteristics (SPC).
   
• Liver damage occurred within 15 days after taking the first dose of nimesulide in one-third of cases.
   
• It is unacceptable that nimesulide still remains on the market in France and other countries: reports of severe liver damage continue to accumulate, and many other therapeutic options are available.  

Full text available for free download.

 ©Prescrire 1 May 2011

"Nimesulide: patients still exposed to a risk of severe hepatitis" Prescrire Int 2011; 20 (116) : 125-126. (Pdf, free)