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Dextropropoxyphene combined products: withdrawn in a third European country

After Switzerland and the United Kingdom, now it is Sweden's turn to announce the withdrawal of the combined products paracetamol + dextropropoxyphene. What is France waiting for?

The combination of paracetamol+dextropropoxyphene is a painkiller on sale in a number of countries. Despite being on the market for several decades, this combination has not been proven to be more effective than paracetamol on its own; on the other hand, it exposes the patient to more adverse effects, some of which can be serious, even fatal. Three European countries have withdrawn or are planning to withdraw products combining paracetamol+dextropropoxyphene, following serious accidents and deaths: Switzerland, the United Kingdom and now Sweden. In these countries, deaths occurred (respiratory failure or cardiac problems), some as a result of unintentional overdoses. The French drugs regulatory agency (AFSSAPS) is hiding behind a study carried out by poison centres to estimate the number of events identified in France (7 deaths a year on average), and does not advocate the withdrawal of this drug from the market. This study, which has not been published in detail, under-estimates the risk. French health authorities should follow the example set by other countries, instead of continuing to allow a drug that is no more effective than paracetamol and which causes a non-negligible number of deaths each year to remain on the market.

©Prescrire October 2005

Source: "Dextropropoxyphène associé : retrait du marché suédois" Rev Prescrire 2005 ; 25 (265) : 665.

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