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Dextropropoxyphene: still on the French market, despite the risks

The combination of dextropropoxyphene + paracetamol was France's second most prescribed reimbursable drug in 2006. It has been withdrawn from the market in several European countries due to its serious adverse effects.

In the 2006 ranking of drugs on the French reimbursement list, the pain relief combination of dextropropoxyphene + paracetamol, with around 48 million packets sold, came in second among the most-prescribed drugs reimbursed by French Social Security, just behind paracetamol on its own (192 million).

This is surprising, given that other countries (UK, Sweden and Switzerland in particular) have decided to withdraw this combination from the market because of the risks it presents. Dextropropoxyphene exposes patients to risks of respiratory depression, disorder of the cardiac conduction system, and even death, notably in cases of kidney failure and in elderly patients.

The October issue of la revue Prescrire strongly criticises the French committee that assesses new drugs’ medical benefits and advises on drug reimbursement (the Commission de la transparence), for concluding that the combination of dextropropoxyphene + paracetamol offered an important medical benefit, while the committee also said that it had no evidence of the combination’s effectiveness as pain relief compared with paracetamol alone. As for the adverse effects, the committee simply stated, "no health risk comparable to that observed in the UK and Sweden has been identified in France".

In Prescrire’s opinion, France should on the contrary withdraw this combination from the market: when a drug offers no demonstrable benefit but presents potential or proven risks, the authorities should protect patients’ rather than pharmaceutical companies’ interests.

©Prescrire1 November 2007

Source: "Dextropropoxyphène + Paracétamol : toujours là, malgré les risques" Rev Prescrire 2007; 27 (288): 735.

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