Withdrawal of co-proxamol

Further to renewed interest, the MHRA position on the withdrawal of co-proxamol:

Co-proxamol is implicated in 300-400 deaths from overdose a year. There is growing concern prompted by UK research which shows that co-proxamol is implicated in almost one fifth of drug related suicides and is second only to tricyclic antidepressants as an agent of fatal overdose. In response, the MHRA/Commitee on Safety of Medicines (CSM) conducted a review of the risks and benefits of co-proxamol. The CSM considered all the available data for co-proxamol and in January 2005 advised that it should be withdrawn from the market on the grounds that the benefits of taking co-proxamol are not considered to outweigh the risks:
› Co-proxamol to be withdrawn from the market - January 2005

It was decided to withdraw co-proxamol over an extended period of time in order to allow long term users an opportunity to move to suitable alternatives. The withdrawal will be phased over a period of up to 36 months. Some manufacturers have already withdrawn co-proxamol and a few will phase the withdrawal until the end of 2007. The MHRA has issued CSM pain management guidance (15Kb) to help doctors find the best options for individual patients. 

We recognise, however, that there is a small group of patients who are likely to find it very difficult to change; when alternatives appear not to be effective or suitable. For these patients, continued provision of co-proxamol through normal prescribing may continue until the cancellation of the licences at the end of 2007. After this time there is a provision for the supply of unlicensed co-proxamol, on the responsibility of the prescriber. Patients wishing to go down this route should discuss this possibility with their doctor.

The avoidable death toll from co-proxamol overdose cannot be ignored. Sometimes regulation has to balance the needs of the individual against the benefits at a population level.  In this case the removal of marketing authorisations with continued use possible in exceptional circumstances is the best balance that could be achieved.  The public health gain is already becoming apparent.

Further information about the withdrawal of co-proxamol is available in:
› Current Problems in Pharmacovigilance: Vol 31 (pages 1-12) May 2006 (247Kb)