- Prescribing Advice for GPs - https://www.prescriber.org.uk -

MHRA clarifies co-proxamol position

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The MHRA announced in January 2005 that co-proxamol would be withdrawn at the end of 2007 following a phased withdrawal.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:

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.