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Dextropropoxyphene-paracetamol combination (Di-Antalvic° and other brands): withdrawn from pharmacies in France

NEWS UPDATEOn 25 June 2009, the European Medicines Agency (EMEA) finally decided to "recommend" the withdrawal from the market of the dextropropoxyphene-paracetamol combination (Di-Antalvic° and other brands). The French Health Products Safety Agency (AFSSAPS) waited for this "recommendation" before deciding to withdraw the combination, unlike drug agencies in other European countries who had already effected the withdrawal, sometimes several years earlier.

The deadly risks linked to the dextropropoxyphene-paracetamol combination have long been known, as has its lack of therapeutic interest compared to paracetamol alone. Since around 2000, several countries have made the decision to withdraw this combination from their markets, including England, Wales, Sweden and Switzerland. In early 2009, an advisory committee of the US Food and Drug Administration (FDA) also recommended the withdrawal of this drug.

In January 2008, the European Medicines Agency (EMEA) implemented a procedure to re-evaluate the drug's risk-benefit balance. Since then, the EMEA refused to inform Prescrire on the progress of this work, considering that the problem was not of "overriding public interest".

For several years, Prescrire has called upon subscribers not to prescribe this drug. The decision by the European and French authorities has been far too long in coming.

It is up to healthcare professionals to inform patients that this combination is too dangerous in comparison to its benefits, and that it can effectively be replaced by other pain relievers, beginning with paracetamol, alone, or if need be, in combination with codeine. It will also be up to healthcare professionals, along with patients, to manage the sometimes delicate transition from one treatment to another.

©Prescrire 26 June 2009

See also:

> Dextropropoxyphene: still on the French market, despite the risks

> Dextropropoxyphene: more deaths

> Dextropropoxyphene combined products: withdrawn in a third European country

European Medicines Agency ‘‘Press release - European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines’’ 25 June 2009.
Document Ref. EMEA/401062/2009, available online at :

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