Healthy Skepticism Library item: 12240
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Nimesulide
ISDB / PharMeD Trade News, Hyderabad 2008 Jan 1
Full text:
International Society of Drug Bulletins (ISDB) Press Release 20 December 2007
Nimesulide must be withdrawn worldwide due to serious liver damage Nimesulide exposes patients to fatal liver damage.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’s 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.
The ISDB is a worldwide network of bulletins and journals on drugs and therapeutics that are financially and intellectually independent of pharmaceutical industry. More info on: www.isdbweb.org
EDITORS NOTE
In India, Nimesulide is not only permitted for use in adults without any limit but also for neonates, infants and children for fever and pain. To our knowledge, India is the only country in the world where Nimesulide is permitted for use in children
