EU wants to withdraw all dextropropoxyphene products
This article was originally published in Scrip
All marketing authorisations for dextropropoxyphene-containing products should be withdrawn in the EU because of the risk of intentional or accidental overdose, the EU's CHMP has recommended. The risk of overdosing only became evident when data from national poison centres and mortality statistics throughout the EU were analysed in depth, the committee adds.
The withdrawal should include products containing dextropropoxyphene alone and those where it is combined with paracetamol, the committee said. The recommendation will now be forwarded to the European Commission to give a legally binding decision. The products are expected to be withdrawn gradually to allow patients to be transferred onto alternative therapies.
The UK withdrew the marketing authorisation for dextropropoxyphene combined with paracetamol (which is called co-proxamol in the UK) in 2005, and last week a published analysis showed that this had been associated with a decline in accidental or intentional overdoses in the following two years in the UK, without an increase in fatalities associated with other products remaining on the market (scripnews.com, June 23rd, 2009).
Dextropropoxyphene has been available in the EU for about 40 years, but safety reviews in different countries have led to different conclusions, the EMEA notes. Sweden withdrew authorisations for co-proxamol in 2005, while co-proxamol (sometimes with caffeine) products are authorised in Belgium, Cyprus, France, Luxembourg, Malta and Portugal, and in the non-EU country Norway. Products containing dextropropoxyphene alone are authorised in 10 EU countries – Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden.
In the US, where dextropropyoxyphene is known as propoxyphene, an FDA advisory panel narrowly voted earlier this year that propoxyphene-containing products (such as Xanodyne's Darvocet, Darvon and generics) should be removed from the market (scripnews.com, February 2nd, 2009). However, there were concerns that alternative analgesics also carry a risk of dependence and abuse, and have not been scrutinised to the same level as propoxyphene. In addition, propoxyphene is usually formulated with a less soluble salt in the US than in the UK, and is prescription only. More recently, Public Citizen sued the FDA for failing to withdraw propoxyphene (scripnews.com, June 25th, 2009).
In the EU, analysis of dextropropoxyphene plus paracetamol's risks and benefits started in November 2007, a review which was widened in March this year to include dextropropoxyphene marketed alone. Initially, the review looked at data submitted by marketing companies and those in the published literature. However, it was only when data from poison centres, coroners' services, hospital statistics, national mortality statistics and toxicology services were analysed that the actual risk of dextropropoxyphene-containing medicines became apparent, the CHMP says.
The review also concluded that dextropropoxyphene was only a weak analgesic, and that co-proxamol was no more effective than paracetamol or ibuprofen alone in short-term pain. In long-term pain, there was no evidence that co-proxamol was more effective than alternative analgesics, the CHMP said.