E-DRUG: ISDB press release nimesulide must be withdrawn
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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Nimesulide must be withdrawn worldwide due to serious liver damage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
Contact: ckopp@prescrire.org
The International Society of Drug Bulletins
The following members supported this press release:
AIS-Nicaragua (Nicaragua)
Andrew Herxheimer (ex ISDB President)
arznei-telegramm (Germany)
Bilten O lijekovima & Pharmaca (Croatia)
BODHI (India)
Boletin Farmacos (Argentina)
Bulletin d?Information du Médicament et de Pharmacovigilance (France)
Bulletins d?Informations de Pharmacologie (France)
Butlleti Groc (Spain)
DER ARZNEIMITTELBRIEF (Germany)
Dialogo sui farmaci (Italy)
DIC Newsletter (India)
Drug Information Center of National University (Colombia)
Farmakon/Slovensko Farmacevtsko Društvo (Slovenia)
Farmakoterapeutické Informace (Czech Republic)
Geneesmiddelenbulletin (the Netherlands)
Gute Pillen Schlechte Pillen (Germany)
Healthy Skepticism Inc (Australia)
Información Farmacoterapéutica de la Comarca/Boletín INFAC (Spain)
Informazioni sui farmaci (Italy)
Kusuri-no-Check (Japan)
La Lettre du GRAS (Belgium)
La revue Prescrire (France)
MEDEX, DrugInfo (Moldova)
PHARMA Drug Bulletin (Israel)
Pharma-Brief (Germany)
Pharmaflash (Switzerland)
Pharmakon (Spain)
Pharma-kritik (Switzerland)
The Belgian Centre for Pharmacotherapeutic Information (BCFI) (Belgium)
The Informed Prescriber (Japan)
Worst Pills, Best Pills News/worstpills.org (USA)
Christophe Kopp <ckopp@prescrire.org>