European Medicines Agency Recommends Withdrawal Of Dextropropoxyphene-Containing Medicines (Including Co-Proxamol)

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Pain / Anesthetics
Article Date: 29 Jun 2009 - 5:00 PDT

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The European Medicines Agency (EMEA) has today announced their recommendation to withdraw the marketing authorisations for dextropropoxyphene-containing medicines (including co-proxamol) across the European Union (EU). This recommendation was made after the Committee on Medicinal Products for Human Use (CHMP) concluded that the risks, particularly of potentially fatal overdose, were greater than the medicine's benefits. The EMEA's recommendation has been forwarded to the European Commission (EC) for a decision which will be legally binding across the EU. In the UK, the only medicine affected by the EMEA's announcement is co-proxamol.

The MHRA announced its decision to withdraw co-proxamol in 2005. Since then the vast majority of patients have managed to find an acceptable alternative, after consultation with their health care professional.

Co-proxamol is a combination of a weak opioid (a weak painkiller), dextropropoxyphene (DXP), with a relatively low dose of paracetamol. There is no robust evidence that co-proxamol offers any advantage over other widely used painkillers, paracetamol or ibuprofen, at normal doses. Co-proxamol is extremely dangerous in overdose as only a small overdose can be fatal, and death can occur very rapidly - before medical attention can be sought.

The MHRA does recognise that there is a small group of patients who have found it very difficult to change from co-proxamol, when alternatives appear not to be effective or suitable. We have worked with the manufacturer to ensure some unlicensed product remains available. As with any unlicensed medicine there is a provision for the supply of unlicensed co-proxamol, on the responsibility of the prescriber, who can judge the risks and benefits in consultation with the patient.

A key part of the National Suicide Prevention Strategy is to reduce ready access to methods of suicide. Co-proxamol has been a significant cause of death from overdose, and its withdrawal has saved the lives of around 300 - 400 people per annum in the United Kingdom from self-poisoning, of which around a fifth were accidental.

The MHRA welcomes the recent paper by Keith Hawton and colleagues highlighting the significant public health impact of the withdrawal of co-proxamol from the UK market.

Source
MHRA