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The MHRA announced in January 2005 that co-proxamol would be withdrawn at the end of 2007 following a phased withdrawal.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 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 change co-proxamol prescriptions to more suitable and licensed alternatives. Where alternatives have been fully explored and have proven unsuitable, unlicensed co-proxamol may be an option.