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No authorisation for etoricoxib!

The harm-benefit balance of cox-2 inhibitor anti-inflammatory drugs is unfavourable. It is inexcusable for a new cox-2 inhibitor to have been authorised for sale and reimbursement in France.

Etoricoxib (Arcoxia°) is set to go on sale in France shortly, as things currently stand.

The harm-benefit balance of this new nonsteroidal anti-inflammatory drug (NSAID) belonging to the cox-2 inhibitor class is unfavourable. Compared to classic NSAIDs, cox-2 inhibitors do not offer better efficacy, nor do they reduce the serious digestive adverse effects. But they do expose patients to greater risks, which can be serious or even fatal, especially a risk of cardiovascular effects.

Because of these risks, a number of cox-2 inhibitors have been withdrawn from the market, in particular rofecoxib (formerly Vioxx°) and valdecoxib (formerly Bextra°). Some medicines agencies have refused to license new cox-2 inhibitors: for example, the United States has turned down etoricoxib and parecoxib.

Following an EU decision, the French Health Products Safety Agency (Afssaps) has finally granted a marketing authorisation for etoricoxib. Furthermore, the French committee that assesses the medical benefits of new drugs and provides recommendations concerning drug reimbursement (Commission de la transparence) has recommended that etoricoxib be reimbursed by the national health insurance system, albeit at a rate of only 35%.

Given the failings of the authorities, it is up to healthcare professionals not to prescribe etoricoxib and to inform patients of the risks of cox-2 inhibitors in general.

To provide relief for patients suffering from osteoarthritis, the first-choice analgesic is paracetamol, or if that is not effective, ibuprofen, or naproxen.

©Prescrire August 2010

"Approval of etoricoxib is unacceptable!" Prescrire Int 2010; 19 (108): 158 (pdf, subscribers only).
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