(2) when co-proxamol will be withdrawn from general use in the relief of pain for sufferers of (a) osteoarthritis and (b) fibromyalgia; and what alternative drugs will be able to be prescribed.;
(3) what (a) discussions she has had with and (b) representations she has received from (i) Arthritis Care, (ii) the Arthritis Research Campaign, (iii) the National Rheumatoid Arthritis Society and (iv) the Fibromyalgia Association on the phased withdrawal of co-proxamol.
There has been growing concern about the safety of co-proxamol, prompted by United Kingdom research showing that co-proxamol alone accounts for almost one-fifth of drug related suicides and is second only to tricyclic antidepressants as an agent of fatal drug overdose. Furthermore, co-proxamol is involved in 300-400 self-poisoning deaths each year.
Many deaths involve people taking co-proxamol that had not been prescribed to them. Co-proxamol is potentially very toxic, and toxic overdose can occur with only a few tablets more than the recommended daily dose. Unlike paracetamol there is very limited opportunity for effective treatment of co-proxamol poisoning and sadly victims often die before they reach hospital.
As a result of these concerns, in 2004 the Committee on Safety of Medicines (CSM) conducted a rigorous review of all the available evidence regarding the risks and benefits of co-proxamol. The review highlighted that there is a lack of evidence that co-proxamol is any more effective than full dose paracetamol, either for short term use or for chronic conditions. During the review a public call for evidence on the risks and benefits of co-proxamol was also conducted. The Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to a large number of organisations representing healthcare professionals, patient groups and other stakeholders. The information gathered provided no new objective evidence concerning the risk and benefits of co-proxamol.
The CSM noted that previously strengthened warnings to doctors and patients on the hazards of co-proxamol had proved ineffective. After considering all the available evidence the CSM determined that the risks of co-proxamol outweigh the benefits of allowing the medicine to remain on the market and advised that co-proxamol should be withdrawn over a period of up to 36 months.
The marketing authorisations for co-proxamol will be withdrawn at the end of 2007. Some manufacturers have already withdrawn co-proxamol and a few will phase the withdrawal until the end of 2007. This extended withdrawal period allows long-term co-proxamol users an opportunity to move to suitable alternatives. There are a number of such alternatives and the MHRA has issued CSM pain management guidance to help doctors find the best options for individual patients. This is available on the MHRA's website at www.mhra.gov.uk.
The MHRA recognises that there is a small group of patients who are likely to find it very difficult to change from co-proxamol or for whom there is an identified clinical need, and for whom 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 will be provision for the supply of unlicensed co-proxamol, on the responsibility of the prescriber.
The MHRA has met with Arthritis Care, the British Society for Rheumatology, the National Rheumatoid Arthritis Society and the British Pain Society to discuss the withdrawal of co-proxamol. As a result of these discussions, an article on the risk and benefit of co-proxamol was agreed for publication in the MHRA's/CSM's drug safety bulletin, ‘Current Problems in Pharmacovigilance’. Arthritis Care, the British Pain Society and the British Society for Rheumatology also responded to the public call for evidence. As is usual for MHRA public consultations, the responses to consultation are available on request.
The outcome of regulatory action to withdraw co-proxamol is being carefully monitored. It is encouraging to see that the latest figures on suicide show that the national suicide rate continued to fall in 2005 and stood at its lowest ever level. Furthermore a recent report from the national programme on substance abuse deaths based at St George's Hospital in London shows that the number deaths involving co-proxamol had declined since the CSM took action.