english.prescrire.org > Spotlight > Archives : 2007 > Nimesulide: a nonsteroidal anti-inflammatory with serious hepatic reactions

Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2007 : 1 | 30 | 60 | 90

Nimesulide: a nonsteroidal anti-inflammatory with serious hepatic reactions

Nimesulide exposes patients to fatal liver damage. When a non-steroidal anti-inflammatory is necessary, it is better to use one with a favourable benefit-harm balance, such as ibuprofen.

It is inexcusable that nimesulide (Nexen°) has been allowed to remain on the market. This non-steroidal anti-inflammatory (NSAID), approved in 1998, offers no therapeutic benefit compared with other NSAIDs, whereas it exposes patients tofatal hepatic disorders.

In 2002, Finland and Spain withdrew nimesulide from the market following reports of serious liver damage. Cases including 2 deaths had also been reported in France at the time. Ireland and Singapore decided to withdraw nimesulide from the market in 2007. Although it has confirmed the hepatic risks associated with nimesulide, in 2007 the European Medicines Agency merely limited the duration of treatment, leaving patients exposed to an unjustifiable and fatal risk. These half-measures are all the more unacceptable since there are numerous NSAIDs available which are just as effective and less dangerous.

How many deaths, liver transplants and cases of hepatitis will it take for nimesulide, whose benefit-harm balance is patently negative, to be withdrawn from the market?

©Prescrire December 2007

Source: "Nimésulide et hépatites (suite)" Rev Prescrire 2007 ; 27 (290) : 907.

- More articles in Prescrire's "Spotlight"...