Healthy Skepticism Library item: 12230

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Publication type: media release

Nimesulide must be withdrawn worldwide
International Society of Drug Bulletins 2007 Dec 20

Full text:

Nimesulide exposes patients to fatal liver damage. When a non-steroidal anti-inflammatory drug is needed, it is better to use one with a favourable benefit-harm balance such as ibuprofen. EU authorities fail to protect consumers.

The International Society of Drug Bulletins (ISDB) deems it unacceptable that nimesulide has been allowed to remain on European and some other markets in the world. This non-steroidal anti-inflammatory drug (NSAID) offers no therapeutic advantage or better gastrointestinal safety compared with other NSAIDs, whereas it exposes patients to a higher risk of fatal hepatic disorders.

Nimesulide has never been approved for use in countries like USA, UK, Canada, Australia New Zealand, Japan and other countries in view of concerns over its safety profile.
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.

The European Medicines Agency has confirmed the hepatic risks associated with nimesulide in 2007, but merely limited the duration of treatment, leaving patients exposed to an unjustifiable fatal risk. These half-hearted measures are all the more unacceptable since numerous other available NSAIDs are just as effective and less dangerous.

How did a majority of EU member states’ rapporteurs who re-assessed nimesulide conclude that the product should remain on the market? Why is there such inconsistency among EU member states?

The Committee for Medicinal Products for Human Use (CHMP) assessed the harm caused by nimesulide in total secrecy and it is quite unacceptable for the EU health authorities to decide to limit only the duration of use without presenting the rationale behind this decision.

EU Commission’ unwillingness to withdraw nimesulide leads to EU citizens being unjustifiably exposed to preventable harm.

Nimesulide must be banned in the European Union and the rest of the world.