english.prescrire.org > Spotlight > Archives : 2009 > Etoricoxib: no to a drug with an unfavourable risk-benefit balance

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Etoricoxib: no to a drug with an unfavourable risk-benefit balance

Despite its unfavourable risk-benefit balance, etoricoxib, a nonsteroidal anti-inflammatory drug, is set to be marketed in France.

Etoricoxib is a nonsteroidal anti-inflammatory drug of the cox-2 inhibitor family. Like other cox-2 inhibitors, it is no more effective than classic nonsteroidal anti-inflammatory drugs and offers no benefits in terms of severe adverse digestive effects.

Because it can sometimes cause severe cardiovascular and skin effects, etoricoxib was refused authorisation in the USA in 2007. For these same reasons, and despite etoricoxib being approved by the European Medicines Agency, the French Health Products Safety Agency (Afssaps) raised major objections in 2002, and again in 2005. And in November 2008, the French Transparency Committee (that assesses the medical benefits of new drugs and advises on drug reimbursement) concluded that the therapeutic benefit (Service Médical Rendu, or SMR) was "insufficient".

But in 2009, the situation was reversed: a marketing authorisation was granted in France and the SMR was adjusted to "moderate".

Rofecoxib (ex-Vioxx°) and other drugs in the same family as etoricoxib have been withdrawn from the market due to the severe, even fatal, adverse effects associated with them.

Let us not repeat the same tragic story with etoricoxib, whose risk-benefit balance is also unfavourable.

Do not prescribe this drug, but opt rather for paracetamol, or, if that is not effective, ibuprofen or naproxen.

©Prescrire October 2009

Source: "Étoricoxib en France : Commercialisation en vue malgré une balance bénéfices-risques défavorable" Rev Prescrire 2009; 29 (311): 656-657.