The Medicines and Healthcare products Regulatory Agency (MHRA) has clarified what is expected to happen following the cancellation of marketing authorisations (MAs) for co-proxamol at the end of 2007.
The MHRA announced in January 2005 that co-proxamol would be withdrawn at the end of 2007 following a phased withdrawal. This decision was reached after a safety review of the risks and benefits of co-proxamol concluded that the “efficacy of co-proxamol is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable”.
The following action points have been recommended:
No further stock released into the supply chain after 31st December 2007
Existing stock already in the supply chain can be supplied until the product expiry date
Manufacturers to withdraw and accept returned surplus stock from the supply chain
For a very small number of patients unlicensed co-proxamol can be supplied, on the responsibility of the prescriber
It is also likely that the price of co-proxamol will increase following the withdrawal of the marketing authorisation.
Action: Clinicians should ensure that audits have been undertaken to identify patients taking co-proxamol. The pain control of all such patients should be reviewed fully and their presciptions changed to more suitable and licensed alternatives. Further information on appropriate pain control can be found on the pain management section of NPC
This article is based on a blog by Matt Robinson and can be accessed at http://www.prescriber.org.uk/