english.prescrire.org > Spotlight > Archives : 2011 > Withdrawal of paracetamol + dextropropoxyphene in France: about time too

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Withdrawal of paracetamol + dextropropoxyphene in France:
about time too

Dextropropoxyphene has adverse cardiovascular effects even in cases of a slight overdose, and especially among the elderly and patients with renal failure. When an opioid is needed, it is better to replace this combination treatment with codeine rather than tramadol.

Products based on dextropropoxyphene + paracetamol were finally withdrawn in France in March 2011, after being on the market for over 45 years.

Dextropropoxyphene’s harm-benefit balance is unfavourable, and in combination with paracetamol, it is no more effective as an analgesic than paracetamol alone. Apart from opioid dependence, it exposes patients to disproportionate risks such as convulsions or cardiac disorder. The elderly and those with renal failure are particularly at risk. Fatalities, even in cases of a slight overdose, deliberate or otherwise, have been reported.

The experience of various countries including Great Britain, Sweden and Switzerland, which withdrew this drug several years ago, or that of some health establishments in France, such as the Toulouse teaching hospital, have shown that it is possible to offer patients relief without using this potentially dangerous combination.

When additional treatment with a weak opioid is justifiable, in particular if paracetamol alone is not sufficient, it is better to prescribe codeine, whose harm-benefit balance is the most acceptable, despite its limitations. Tramadol (both alone and combined with paracetamol) should be avoided, notably because it can cause neuropsychological disorders (including convulsions) and hypoglycaemia, or cause adverse respiratory and cardiovascular effects.

©Prescrire 1 May 2011

Source: "Dextropropoxyphène + paracétamol : enfin retiré en France en mars 2011" Rev Prescrire 2011; 31 (328): 99.

See also:

Dextropropoxyphene and
cardiac disorders: new data
Prescrire Int 2011;
20 (113): 45
Pdf, free

+ paracetamol to be
withdrawn from the European
market by September 2011
at the latest
(October 2010)

combination (Di-Antalvic° and
other brands): withdrawn
from pharmacies in France
(June 2009)