Co-proxamol

On 4 August 2008, in a report broadcast on BBC Breakfast, a representative from the MHRA claimed that "supplies [of co-proxamol] were being assured".

The report, produced with support from Arthritis Care, looked at the availability of co-proxamol since the drug was withdrawn. In contrast to the statement from the MHRA, the BBC discovered that co-proxamol is not getting to some of the people that really need it, reflecting the concerns of the people that have contacted Arthritis Care.

For more information, you can see an article on the BBC's website by clicking here.

Arthritis Care's Director of Public Affairs, Rachel Haynes, also spoke about the issue on BBC Radio Kent.

The Medicines and Healthcare products Regulatory Agency (MHRA), the government body responsible for drug safety, has now withdrawn market authorisation for co-proxamol.

Despite extensive campaigning efforts from various organisations and individuals, the restrictions went ahead as planned.

For people who have not been able to find an appropriate alternative to co-proxamol, the MHRA have made the following statement:

"We recognise that there is a small group of patients who are likely to find it very difficult to change from co-proxamol or where alternatives appear not to be effective or suitable. For these patients, following cancellation of the licences at the end of 2007 there is a provision for the supply of unlicensed co-proxamol, on the responsibility of the prescriber". 

You can find the full text of this statement at the following link:

Position on the sale and supply of co-proxamol following cancellation of the marketing authorisations at the end of 2007

We would be very interested to hear of your experiences in trying to obtain co-proxamol. We are continuing to collect your stories as evidence of how the MHRA's decision on co-proxamol is working in practice and to drive forward our work on this important issue. Please email us at campaigns@arthritiscare.org.uk.

If you have any concerns over your medication or need to seek an alternative to co-proxamol, please consult your GP. If you need more immediate support and information, the Arthritis Care helpline is available to answer any specific questions you may have on all aspects of arthritis: Call free on 0808 800 4050, weekdays 10am to 4pm.

Throughout 2007, GPs were urged by the Medicines and Healthcare products Regulatory Agency (MHRA) to attempt to transfer all patients using co-proxamol to other forms of medication. For some people, however, the alternatives may have been ineffective. Therefore, co-proxamol could still be prescribed under normal prescribing procedures until the end of December 2007, provided that:

• the doctor believes that co-proxamol is the only suitable painkiller for a particular individual
• that doctor is confident that their patient both understands and will follow strictly their advice on how to take it
  

The MHRA decided that after 2007, co-proxamol will be available on a ‘named patient’ basis only, subject to stocks. This means that GPs are still able to prescribe co-proxamol, but only under strict conditions.

Arthritis Care believes that this form of availability is not the best way of ensuring that the small number of people who need co-proxamol continue to get it after 2007. The charity will therefore continue to argue for a review of how best to make co-proxamol available.

Two MPs, working closely with Arthritis Care and the British Society for Rheumatology, have put co-proxamol back on the agenda in the House of Commons.

MPs Anne Begg and Howard Stoate raised an adjournment debate amid growing concern that the move to ‘named patient’ prescribing after the end of 2007 would not work as GPs would be reluctant to accept the additional liability burden that would be involved.

Although no immediate change was proposed by health ministers during the debate, it is expected that discussions will now be held to see if a practical solution to the problem can be found.

“We have suggested that co-proxamol could be made a controlled drug,” said the campaigns team at Arthritis Care. “This may be the best way to ensure supply to those who really cannot do without it whilst restricting access to what is a powerful painkiller. However, the key thing is that the MHRA (the UK’s drug regulatory body) and the Department of Health should come up with a way of balancing the need to keep prescriptions to a minimum and the need, which they acknowledge, to continue supplies in exceptional circumstances.”

Link to Hansard record

The Medicines and Healthcare products Regulatory Agency (MHRA) announced in January 2005 that co-proxamol would be gradually withdrawn. It felt the benefits of co-proxamol did not outweigh the risks.

Co-proxamol is considered a dangerous drug in overdose and is believed to be involved in 300-400 deaths each year in the UK, one fifth of them accidental overdose and the rest suicide.

• Co-proxamol can be fatal if the prescribed dosage is even slightly exceeded and particularly so if mixed with alcohol
  

• The effects are fast-acting and so any medical intervention is often too late
  

• For the great majority, other drug treatments should be just as effective

Arthritis Care worked with the British Society for Rheumatology and other bodies to try and achieve two objectives.

1) To clarify the prescribing rules governing co-proxamol prior to its intended withdrawal

2) To seek a review of the decision to withdraw co-proxamol

Following urgent consultations with the MHRA the situation on prescribing rules was eventually clarified.

In a limited consultation conducted by the MHRA prior to the withdrawal announcement, Arthritis Care had advocated new and stringent safety precautions but opposed withdrawal because many people using co-proxamol found that other medicines did not control their pain adequately.

Arthritis Care Statement

Arthritis Care responded to the original MHRA announcement stating:

‘The gradual withdrawal of co-proxamol is bad news for people with arthritis. For many people, paracetamol on its own doesn’t ease their pain; NSAIDS carry a risk of gastro-intestinal bleeds; many doctors are reluctant to prescribe Cox-2s; and the alternative compound pain relievers such as co-dydramol and co-codamol will not suit everyone with arthritis as they can cause severe constipation, a particular problem for older people.

‘Although we understand the MHRA’s concern, we are of the view that a stringent package of prescribing advice, packaging changes and other warnings should limit the risks of co-proxamol being misused. The withdrawal of co-proxamol leaves many people with very few options for the safe and effective management of their pain.’

Arthritis Care is keen to hear from anyone who has experienced difficulties when taken off coproxamol or whose condition has improved once they have started to take it.

We are also interested to know of any difficulties in obtaining the medicine despite having a prescription e.g. if pharmacies have had trouble getting supplies.

Use our 'Your experience' form to submit your testimony