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‘No new evidence’ for NICE advice on paracetamol, says MHRA



Exclusive The medicines regulator has flatly contradicted NICE saying it has ‘no new evidence’ to support draft guidance released by the institute earlier this month urging GPs not to use paracetamol routinely in osteoarthritis.

The NICE guidance said GPs should use the ‘lowest effective dose’ for the ‘shortest possible time’, but the Medicines and Healthcare Products Regulatory Agency told Pulse that current evidence does not support any change in the use of paracetamol for osteoarthritis.

NICE claims that their analysis of recent observational data shows the benefits of paracetamol in osteoarthritis are much lower than previously thought, while the risks of adverse events with the drug are much higher.

But now this intervention by the MHRA puts this analysis into doubt, while many GPs say that the new guidance is impractical, particularly after problems with many other analgesics have narrowed their choices for patients with chronic pain.

The GPC said that it was ‘struggling’ with the reasoning behind the recommendation, that was a complete surprise for many GPs.

The MHRA spokesperson said: ‘On the basis of the information currently available, there is no new evidence that would change the benefit–risk balance of the use of paracetamol in the care and management of osteoarthritis.

‘As with any draft guideline, there should be no change in the current use of paracetamol in the care and management (of osteoarthritis in adults) until such time as the guideline is finalised.’

A spokesperson from the MHRA told Pulse the Commission on Human Medicines will be submitting a formal response to the consultation.

The NICE guideline development group said it was ‘extremely concerned’ about its links to possible fatal events with paracetamol, and warned for GPs to avoid its use with NSAIDs.

Dr Dermot Ryan, a GP in Loughborough and honorary research fellow at University of Edinburgh, says – if adopted – the NICE advice would have wide-ranging implications.

He says: ‘Where do you go next? You go to the opioids, so then patients get constipation so they need lactocellulose, or they get faecal impaction and sometimes need to go into hospital because of an obstruction. And sometimes the opioids affect them mentally, making them sleepy all the time, or confused. So you go down this avenue where you end up asking which is worse – paracetamol or the opioids?’

Dr Bill Beeby, the GPC’s prescribing subcommittee chair and a GP in Middlesborough, confessed he was ‘struggling’ with the reasoning behind it.

He added: ‘This is a guarantee for treatment failure, and since the psychology of the healing power of doctors often requires the use of a token in the form of a prescription, may well lead to less desirable medications being used.’ 

But Professor Martin Underwood, professor of primary care research at Warwick University and a GP in Coventry, told Pulse he feels the new NICE recommendation is reasonable, having gone through the evidence presented in the draft document.

He said: ‘In osteoarthritis the evidence for its effectiveness is weak and it probably only has a small effect. That small effect size, set against the wider observational evidence for paracetamol having more adverse events than we previously thought, on average means the balance of risks and benefits would not justify using it.

‘So I think it’s an appropriate recommendation – it is saying do not routinely prescribe, so it is not advice not to prescribe. If an individual patient gets a substantial benefit from paracetamol, that would be a justification of continuing to use it even though we are more aware of its adverse events – but the patient should be aware the adverse events are greater than previously thought.’

Professor Underwood added: ‘It’s setting up a flag to say that paracetamol is not the safe, effective harmless we thought it was and we do need to be thinking about what we can offer in terms of non-drug treatments for people with osteoarthritis.’