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Dextropropoxyphene + paracetamol to be withdrawn from the European market by September 2011 at the latest

The European Commission has decided to withdraw dextropropoxyphene-based drugs from the market by mid-September 2011 at the latest.

At the end of June 2010, the European Commission finally rubber-stamped the withdrawal of dextropropoxyphene-based products from the EU market. In France, dextropropoxyphene is commercialised in combination with paracetamol or with paracetamol and caffeine.

This withdrawal, which has already been in effect in several countries for some years, was decided on because of this drug’s unfavourable risk-benefit balance. In particular it exposes patients to a risk of overdose which may be fatal, even when the overdose is slight.

At the end of June 2009, the French Health Products Safety Agency (Afssaps) announced the gradual withdrawal of drugs containing dextropropoxyphene, over a period of one year. But by the beginning of August 2010, this decision had still not been implemented.

In France, in practice, doctors should no longer prescribe drugs containing dextropropoxyphene to new patients.

To find the best alternative to dextropropoxyphene, patients and their doctors should together re-appraise the need for an analgesic, and consider another analgesic with a lower risk: appropriate doses of paracetamol, ibuprofen, and, in some cases, codeine rather than tramadol.

©Prescrire October 2010

Source : "Dextropropoxyphène.Retrait au plus tard en septembre 2011 dans l'Union européenne" Rev Prescrire 2010; 30 (323): 662.