english.prescrire.org > Spotlight > Archives : 2014 > The anti-inflammatory drug nimesulide has been withdrawn from sale in France, at long last

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The anti-inflammatory drug nimesulide has been withdrawn from sale in France, at long last

Patients could have been protected sooner from this drug, which is no more effective than others but can cause serious liver damage.

As of the end of 2013, drugs containing nimesulide have been withdrawn from sale in France. Nimesulide is no more effective than other nonsteroidal anti-inflammatories (NSAIDs), and carries a risk of liver damage that is twice as great.

From 2002 onwards this adverse effect caused nimesulide to be withdrawn from sale in certain European countries. This led to several re-evaluations by the European Medicines Agency, following which the marketing authorisations for nimesulide were maintained, with some restrictions on use, requirements that healthcare professionals be informed, and monitoring of the number of liver transplants linked to nimesulide.

As of late 2011, France's Pharmacoeconomic Committee, which assesses the medical benefits of new drugs and advises on drug reimbursement, struck nimesulide-based medicines off the list of drugs approved for reimbursement and for institutional use. It is likely that this measure reduced the number of prescriptions, prompting pharmaceutical companies to stop selling the drug in France.

©Prescrire 1 March 2014

"Nimesulide: good riddance to a dangerous NSAID in France" Prescrire Int 2014; 23 (147): 72. (Pdf, subscribers only).
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For more information:

In the May issue of
Prescrire International:
Nimesulide - patients still exposed
to a risk of severe hepatitis
(May 2011)
Free

Fatal hepatitis with nimesulide:
the European Commission
drags its feet
(October 2010)
Free