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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

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The MHRA announced in January 2005 that co-proxamol would be withdrawn at the end of 2007 following a phased withdrawal.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

  • 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.

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11 Comments to “MHRA clarifies co-proxamol position”

  1. […] MHRA in 2007  […]

    Pingback by Inside Health – co proxamol/ meningitis B vaccination 23/2/16 | Margaret McCartney's Blog — February 23, 2016 #

  2. I am 67 and suffer from fibromyalgia, various forms of arthritis and scoliosis following a back injury, plus spinal stenosis. My digestive system has been wrecked by taking anti inflammatories, and drugs such as codeine and DF118s make me violently ill. The only pain killer I can take with no discernable side effects is coproxamol, which I was prescribed until October this year when, following the retirement of my old GP, the surgery arbitrarily and with no consultation, no apology or any kind of consideration for my welfare, stopped it completely. I suffer from severe pain, especially at night and especially when my back goes pop. I find it hard to function on anything approaching a normal level. I have forgotten what it is to have a pain free normal active life. Coprox was not the complete answer but it made a difference. Now I have nothing but a few weeks tablets left and I am afraid to use them in case I become desperate. I have tried to complain to the practice, NHS England, even the GMC and they are none of them interested. I could crawl away and die for all they care. In fact I really think they wish I would. There seems to be no redress unless you are rich enough to be able to buy supplies abroad, which I would if I could, or to take it to a solicitor. I really wonder for who's benefit doctors surgeries exist nowadays. Certainly not the patient. I am suffering side effects now from another medication (an anti depressant of all things) that is supposed to replace the coprox. It is making me more ill than my illness. magnifying all my symptoms such as dizziness and constant headaches, and giving me severe anxiety attacks to the point where I walk about shaking. I cannot drive because of this, and so am effectively housebound unless I can get a lift which is making me very depressed, a rather paradoxical situation. The whole thing is disgusting! Hippocratic Oath my eye!

    Comment by A Leach — December 5, 2013 #

  3. I have been taking co-proxamol for more years than I can remember (I am 70) I only take them when required and have never found them addictive.
    My doctor has changed to Co-codamol which I find useless as all they do is make me sick.
    I think who ever got the idea to ban co-proxamol needs to ask the patients first


    Comment by J Mills — November 6, 2011 #

  4. Has anyone been able to source supplies of co-proxamol, if so I would be pleased to know where, cheers John

    Comment by J Mount — June 2, 2010 #

  5. Having fractured my spine I found the best pain control was co-proxamol/Distalgesic. I never got addicted and nor did I have any side effects. Now I have tried a number of substitute analgesics. None have worked and I have spent the last few years in varying degrees of pain and side effects.
    It seems to me the Nanny state has been at it again and a great number of people are suffering because of it. Many people are now spending a great deal of time and money sourcing Co-proxamol abroad. Revenue lost to Britain.

    Comment by Anna McKnight — February 17, 2010 #

  6. [...] Prescribing Advice for GPs MHRA clarifies co proxamol position Posted by root 22 minutes ago (http://www.prescriber.org.uk) I have severe osteoarthritis which required an arthroscopy on my right knee five years i sincerely hope that enough people will comment on their experiences and that we can with no ill effect for a degerative condition of the cervical and lumbar spine pre Discuss  |  Bury |  News | Prescribing Advice for GPs MHRA clarifies co proxamol position [...]

    Pingback by Prescribing Advice for GPs MHRA clarifies co proxamol position | Joint Pain Relief — June 8, 2009 #

  7. I have had been taking co-proxamol for ten years with no ill effect for a degerative condition of the cervical and lumbar spine. I have had one fusion and have general arthritis. The withdrawal of co-proxamol has given me considerable problems with pain and the alternatives prescribed do not work. I am currently waiting for admission to hospital for facet joint injection. I would like to purchase co-proxamol if available. Those that made the decision to withdraw this product should endure the degree of pain the condition causes.

    Comment by Mr E. D. Peare — December 12, 2008 #

  8. Dear Sirs,

    I could not agree more with the comments made by Mrs. Hill, as I have discovered today that my GP may no longer prescribe this drug to me.

    I have severe osteoarthritis which required an arthroscopy on my right knee five years ago and future knee replacement. The arthroscopy trimmed torn cartillages and was followed by debridement. I do not have a low pain threshold, but due to osteoarthritis in my hands, neck and spine, am never pain free.

    I cannot take diclofenac or ibuprofen in 400 mg dosage, and am still taking Lansoprazole to repair the damage done to my stomach. As a result of this I was prescribed co-proxamol. Like Mrs Hill I do not take this lightly.... I take a dose in the morning to help with pain and stiffness on waking and occasionally a dose last thing at night to ensure comfortable sleep. Mostly I take the morning dose and then use Paracetamol 1G during the rest of the day, if pain is "bad". Paracetamol 1G does not cut the pain and I really don't like having to take doses qds. I have tried the other suggested drugs, prior to going onto co-proxamol and all had side effects which were unacceptable.

    Like many others I must ask that this decision be reconsidered, I work as an Arthritis Care volunteer trainer and have received many comments about the withdrawal of this drug, both from osteoarthritis sufferers, as well as rheumatoid sufferers. Effective pain relief is the only way those with arthritis can continue to contribute to the "world of work". I am sure the Government do not want more people following the benefit route, due to incapacity because of chronic pain. Being able to operate effectively, contending with a long-term condition, is essential to a person's mental as well as physical wellbeing.

    I sincerely hope that enough people will comment on their experiences and that we can persuade those who have not experienced crippling pain of long-term conditions will reconsider their decision.

    Comment by Mrs Bolado — August 6, 2008 #

  9. Dear Sirs

    I am 65 years old and have been on this drug for over 30 years. I was first prescribed in when I lived in Guernsey for chronic back pain in boxes of 600 at a time. When returning from Guernsey I had back surgery and for a long time I was fine (THIS BEING SOME 25 YEARS AGO). One Doctor in my practice said it was addictive but I have never found this, I take it when needed and leave it alone for weeks at a time. If this were the case I would live on them all the time.

    I am also prescribed diclofenac which is also wonderful and when on this I have to take both because I can't continue to move if I don't.

    My Doctor has been prescribing co-proxamol to me and he gave me a prescription for them at my last visit although I didn't ask for them as he said that they will soon be not available.

    To my mind if somebody is contemplating taking their own lives with co-proxamol, surely if these were not available some other drug would be taken.

    I always think it strange that there should be a limit of 100 tablets aspirin at any one time from a chemist bearing in mind one could buy bottles 500 at one time. If I needed for any reason more than 100, I could go to more than one chemist buying 100 from each. All these rules are stupid and treat everyone as if they haven't got a brain in their head.

    If these tablets are stopped I for one will be trying anyway to get hold of them privately. There is no other drug on the market that is as good and the others anyway seem to have a lot of side effects which are always unwelcome.


    Mrs Hill

    Comment by Mrs Odette Hill — August 4, 2008 #

  10. [...] Drug Tariff price for co-proxamol has been increased dramatically following the withdrawal of the marketing authorisations at the end of [...]

    Pingback by Prescribing Advice for GPs » Co-proxamol price increase — April 25, 2008 #

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