Doctors are handing out 10,000 NHS prescriptions a year for an unlicensed painkiller that is linked to suicides and accidental overdoses.
The drug, co-proxamol, is considered both dangerous and ineffective and can trigger breathing difficulties, heart-rhythm problems and heart attacks. Yet scores of patients are dependent on the tablets, claiming nothing else works with the long-term pain conditions they suffer – and despite warnings from health chiefs, some GPs and pain consultants feel they should keep providing it.
In 2020 alone, the NHS spent £2.5 million on the drug. Users say they have also obtained co-proxamol via private prescriptions, paying as much as £1,000 a month.
Ailsa Bosworth, founder of the National Rheumatoid Arthritis Society, pictured, took co-proxamol for the condition for decades before her doctor stopped prescribing it in 2015. Soon after beginning the treatment, she had a few small glasses of wine and suffered a potentially deadly side effect
Its licence was withdrawn in 2005 by drugs watchdog the Medicines and Healthcare products Regulatory Authority (MHRA). However, it is still available as an unlicensed drug for people who can’t find a suitable alternative.
One woman who suffers rheumatoid arthritis says: ‘Without co-proxamol, I’m in agony. I struggle to wash or dress myself, let alone anything else. I only need six tablets a day and that changes everything. It means I can get up and about, I can look after my grandchild, I can help at charity events – I feel like I am living.’
The 72-year-old from London, who we are calling Jane to protect her identity, adds: ‘I have tried literally everything and I just found nothing else really works for this kind of chronic pain. Most of the alternatives, such as codeine or morphine, had horrible side effects like stomach problems or made me so drowsy I had to go to bed.’
Jane is reluctant to give details about how she obtains co-proxamol but indicates it comes from overseas. She also claims her private pain consultant in the UK knows she is taking it, but won’t offer her a prescription.
Studies have shown that co-proxamol is no more effective as a painkiller than paracetamol, despite being 28 times more likely to kill you if you overdose. But Jane insists she, and others like her, need the medication. ‘Obviously I have tried paracetamol, but even on the maximum daily dose it wasn’t working anywhere near as well,’ she says.
‘Co-proxamol is the only thing that keeps me going and makes me feel I can live a relatively normal life.’
Studies have shown that co-proxamol is no more effective as a painkiller than paracetamol, despite being 28 times more likely to kill you if you overdose
However, pain expert Dr Nigel Kellow at The Wellington Hospital in North London warns: ‘There is no justification whatsoever for co-proxamol still being prescribed. It is a dangerous drug which was withdrawn for a good reason a long time ago.’
My close call when I took co-proximol… then had a drink
Ailsa Bosworth, founder of the National Rheumatoid Arthritis Society, took co-proxamol for the condition for decades before her doctor stopped prescribing it in 2015.
But it was in the early days of taking it that she had a wake-up call as to how risky it could be.
‘I didn’t realise then how dangerous it could be when mixed with alcohol,’ Ailsa says.
‘I had a couple of small glasses of wine at a Christmas party after taking co-proxamol to manage a flare of my condition.
‘It wasn’t long before I had to be taken home and put to bed.
‘I never drank on it again, but I can see how easy it could be for something to go wrong, especially when alcohol is involved.’
She initially struggled with the alternative painkiller she was offered – co-codamol – but says she has now adjusted and feels the vast majority of patients have done the same.
‘I can absolutely see why they had to withdraw co-proxamol. Quite a few people died accidentally, so the regulator has done the right thing,’ she says.
‘On the whole, people have accepted it is no longer available and just got on without it. If some people are still using it, I’m sure they are using it sensibly and carefully.’
Co-proxamol, sometimes known by the trade names Distalgesic, Cosalgesic or Dolgesic, is a combination of the weak painkiller dextropropoxyphene and a low dose of paracetamol, and it was once one of the most commonly prescribed drugs in England.
It binds to receptors within the nervous system to dull the body’s sense of pain, but can cause respiratory depression, where the lungs don’t take in oxygen or remove carbon dioxide efficiently, as well as interfere with the electrical activity of the heart, potentially triggering heart attacks or heart failure.
In addition, it is relatively easy to overdose on it accidentally, because the margin between the amount needed to feel the painkilling effect and a toxic dose is very small, with some people reportedly dying from as few as two extra tablets.
The effects are worsened by alcohol, and death can occur very quickly – often within an hour.
Co-proxamol was patented in 1955, but by the mid-1960s concerns started being raised about unexpected deaths and its use in suicide. In 1985, health authorities labelled it ‘less suitable for prescribing’ in an attempt to dissuade GPs from handing it out. But up to 400 people every year continued to die after taking co-proxamol – about a fifth of them accidentally. By the late 1990s, it was responsible for one in 20 of all UK suicides and one in five of those involving drugs.
As the evidence against co-proxamol grew, in January 2005 the MHRA announced it was withdrawing its licence, with the change coming into effect by the end of 2007. This meant it was no longer regulated for safety, and doctors could prescribe it only if they took personal responsibility for the consequences – if the patient has an adverse reaction or dies, they could be struck off or face legal action.
Following the withdrawal, prescriptions for co-proxamol in England plummeted from about 7.2 million a year in 2004 to around 275,000 by 2009.
As a result, some 600 deaths – including 500 suicides – had been prevented by 2010, according to an Oxford University study. Researchers found no compensatory increase in other drug deaths, despite a significant increase in prescriptions for painkillers such as co-codamol, paracetamol, co-dydramol and codeine – clearly indicating that co-proxamol itself, not just painkillers in general, was a risk.
Following the success of the UK’s withdrawal, similar bans followed in Europe, the US and Canada, among others. The case against co-proxamol seemed clear-cut – but the statistics tell only half the story.
Many doctors and patients disagreed with the statement made in 2005 by Professor Sir Gordon Duff, then chairman of the Committee on Safety of Medicines, that there was no one for whom the benefits of taking co-proxamol outweighed the risks.
And a poll in the medical magazine Pulse in 2006 found that 70 per cent of GPs and 94 per cent of rheumatology consultants – experts in treating arthritis and other painful joint conditions – wanted the decision to withdraw it reversed. During a House of Commons debate on the issue in 2007, GP and then-Labour MP Howard Stoate quoted one consultant who claimed it was an ‘invaluable’ drug for patients with chronic rheumatic pain. ‘Its withdrawal has caused enormous distress for a large number of patients who have found it to be safe, effective and free of side effects,’ he added.
Many patients who have been using co-proximol said they wanted the drug reinstated
Since then, many chronic pain patients with illnesses such as rheumatoid arthritis or degenerative spine conditions have campaigned for co-proxamol to be reinstated.
‘The problem with finding alternatives is that we have very few pharmacological options available,’ says Professor Philip Conaghan, a rheumatologist at Leeds University and the charity Versus Arthritis.
He explains that many opioids – a class of strong morphine-like painkillers that includes co-proxamol – can cause dependency or addiction, while non-steroidal anti-inflammatory drugs such as ibuprofen can cause complications for people with heart or kidney disease. ‘This very much highlights the need for more research into better treatments, and more safe and effective medicines for people with chronic pain and arthritis,’ he adds.
Dr Arun Bhaskar, president of the British Pain Society, as well as a pain consultant at Imperial College Healthcare NHS Trust and the private Leva Clinic, believes that although there are risks, some patients might benefit from taking co-proxamol. This is because some people feel no benefit from other types of opioids, such as codeine, because their body lacks a particular enzyme needed to process them. ‘How do we justify denying somebody a medication when they claim it works a treat for them?’ he says.
Although studies show co-proxamol works little better for long-term pain than paracetamol, he adds: ‘As a pain consultant, my job is to ensure patients are happy and managing their pain. What’s wrong with a placebo effect?
‘With a purely scientific hat on, I have to go by what the published evidence says. But there is a small group of patients who swear by it. They have tried everything else and it hasn’t worked.’
Dr Bhaskar believes most patients still taking co-proxamol are highly aware of the risks.
‘The analogy I use is that we all have kitchen knives in our houses but most of us are able to use those without harming ourselves or others,’ he explains.
‘These are people who are completely switched on and are very responsible about how they take their medications. Their treating doctors have gone through the alternative options and safety checks and felt this was the best option for them.’
But Dr Kellow, who specialises in treating back pain, argues the only reason NHS patients are receiving co-proxamol is because GPs are either unwilling or unable to challenge stubborn patients or find time to review their medications.
‘There will be a small number of patients who are very resistant to stopping or changing medication because they are addicted to it,’ Dr Kellow adds. ‘It can be quite difficult for a GP because they don’t want the relationship of trust to break down, so sometimes it’s easier to keep them on it.’
One GP admitted as much when they revealed why they were still prescribing co-proxamol in an anonymous entry in the online pharmacy journal C&D. ‘I should have enough gumption to simply say “Enough and no more” to my tiny handful of co-proxamol devotees,’ the GP wrote. ‘But, in reality, when you’re running late, they’ve got numerous other symptoms still to sort, the ten-minute clock is ticking and the waiting room is heaving, it’s hard not to bail out by doing what’s most expedient.’
In the meantime, the cost of co-proxamol rocketed from an average of £1.40 per prescription in 2004 to £252 in 2020.
Professor Martin Marshall, chairman of the Royal College of GPs Council, says doctors are concerned by blanket bans of any drug and must be allowed to use their discretion. He adds: ‘It is vitally important that GPs continue to be able to make decisions, based on their expert training and experience, in the best interests of individual patients, taking into account their unique physical, psychological and social circumstances.’
Are you still taking co-proxamol?
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Until 2015, patients deemed to need co-proxamol could be given it on a so-called named patient basis, which allowed GPs to prescribe some unlicensed drugs. But it was removed from the list of treatments available to the NHS, meaning it was only available as an expensive ‘special item’ prescription.
Then in 2017, NHS England added it to an additional list of treatments GPs should not prescribe – but they still can, legally, if they are able to prove there is no other treatment they can offer to relieve their patients’ symptoms.
‘For co-proxamol, which doesn’t work very well compared with other medicines, the risk of overdose is not worth taking,’ states an NHS leaflet handed out to patients who want the drug. It also makes clear cost is an issue, adding: ‘The price is too high for a drug that doesn’t work as well as others.’
It means that while the number of prescriptions for the drug has fallen by 99.8 per cent over the past 15 years, the NHS’s annual bill for it has only dropped from £10 million to £2.5 million.
‘The price is likely to have been put up by the manufacturer to recoup their losses in the number of people who are being taken off this medication,’ says Hussain Abdeh, superintendent pharmacist at Medicine Direct.
Unsurprisingly, the number of GPs willing to prescribe a drug now considered both unsafe and expensive continues to dwindle.
There has also been a shift in the way chronic pain is treated.
With about one in three Britons in daily pain – driven by an ageing population and rising obesity levels – doctors are moving from handing out repeat prescriptions of painkillers which, evidence shows, may cut pain by only about 30 to 50 per cent. Instead they are advised to encourage other forms of pain relief, including heat packs and exercise
With about one in three Britons in daily pain – driven by an ageing population and rising obesity levels – doctors are moving from handing out repeat prescriptions of painkillers which, evidence shows, may cut pain by only about 30 to 50 per cent. Instead they are advised to encourage other forms of pain relief, including heat packs and exercise.
Treatment delays caused by Covid may have changed this picture – research suggests the number of patients using powerful opioid painkillers while awaiting surgery has increased by 40 per cent compared with pre-pandemic levels.
Dr Kellow says patients taking co-proxamol should ask their GPs for help switching to an alternative – and GPs should seek out patients to make sure they come off it.
‘Co-proxamol has been discontinued for a very good reason and we should comply with the rules instead of seeking out loopholes and exceptions,’ he adds.
Safer paracetamol could cause liver failure in the thin and frail
Elderly and frail patients could suffer life-threatening illness after being given paracetamol, a safety watchdog has warned, following the death of an 82-year-old woman prescribed the over-the-counter painkiller in hospital.
Investigators at the Healthcare Safety Investigation Branch say hospital staff failed to spot that the woman, who was admitted after a fall in her kitchen, was too underweight to take the drug.
The watchdog, which investigates harm done to NHS patients, said daily doses of paracetamol could cause liver failure in severely underweight patients such as the elderly, and ultimately lead to death.
Elderly and frail patients could suffer life-threatening illness after being given paracetamol, a safety watchdog has warned, following the death of an 82-year-old woman prescribed the over-the-counter painkiller in hospital, picture posed by model
The report, published last week, follows two other cases of NHS patients with low body weight who died in 2016 after receiving paracetamol in hospital.
While the drug has few side effects for most people, one of its components can be potentially toxic to the liver.
Most people can filter out this toxic product, but people who are severely underweight often have impaired liver function. In these cases, large doses of paracetamol can severely damage the liver, causing it to fail.
In January 2020, the woman, identified only as Dora, was admitted to an unnamed hospital.
The investigators found that Dora was taking co-codamol – a prescription painkiller containing paracetamol – and was prescribed more paracetamol when she arrived at the hospital. However, staff did not weigh Dora for 12 days. When they did, they found she weighed just over six stone – nearly five stone lighter than the UK female average.
But Dora stayed on paracetamol for nearly two weeks more, until her condition deteriorated and doctors realised she was suffering organ failure. Paracetamol was withdrawn but she died, and an inquest concluded that paracetamol-induced liver failure was a cause in her death.
The watchdog concluded that in future, hospitals should consider weighing patients before offering them paracetamol, and patients who weigh less than 50kg – just under eight stone – should not receive daily doses.