Exclusive NICE has been forced into a U-turn on previous advice not to routinely prescribe paracetamol in patients with osteoarthritis, following criticism that the recommendation would have a drastic impact on GP analgesia management.
A leaked copy of NICE guidelines – to be published tomorrow – recommends GPs continue prescribing paracetamol as a first-line analgesic option in osteoarthritis, completely reversing previous draft guidance saying that the drug should be avoided.
The dramatic climb-down comes after medicines regulators rejected NICE’s concerns about patient safety and experts said the move to restrict paracetamol could put patients at risk through greater opioid use.
An advance copy of the final guideline – seen by Pulse – says that NICE now wants to set up a full review of pharmacological management of osteoarthritis to update the guidance at a later date.
It recommends in the meantime GPs should continue to prescribe the drug in line with the 2008 guidance on osteoarthritis.
It says: ‘Healthcare professionals should consider offering paracetamol for pain relief in addition to core treatments; regular dosing may be required. Paracetamol and/or topical [NSAIDs] should be considered ahead of oral NSAIDs, [COX-2] inhibitors or opioids.’
The guideline does say that there are still problems with the safety of current paracetamol prescribing advice and that GPs should take ‘into account’ evidence that paracetamol is less effective than previously thought when prescribing it.
But the final guidance says that the institute had responded to ‘stakeholder feedback’ and had changed its mind on the use of paracetamol.
It says: ‘Stakeholder feedback at consultation indicated that the draft recommendations, particularly in relation to paracetamol, would be of limited clinical application without a full review of evidence on the pharmacological management of osteoarthritis.
‘NICE was also aware of an ongoing review by the MHRA of the safety of over-the-counter analgesics. Therefore NICE intends to commission a full review of evidence on the pharmacological management of osteoarthritis, which will start once the MHRA’s review is completed, to inform a further guideline update.
It adds: ‘In the meantime, the original recommendations (from 2008) remain current advice.
‘However, the Guideline Development Group (GDG) would like to draw attention to the findings of the evidence review on the effectiveness of paracetamol that was presented in the consultation version of the guideline. That review identified reduced effectiveness of paracetamol in the management of osteoarthritis compared with what was previously thought.
‘The GDG believes that this information should be taken into account in routine prescribing practice until the intended full review of evidence on the pharmacological management of osteoarthritis is published.’
The climb-down comes after concerns from the RCGP, the Primary Care Rheumatology Society and the British Rheumatology Society that removal of paracetamol from the ‘analgesic ladder’ without proper analysis of the overall pharmacological management of pain relief would have major knock-on effects and risked putting more patients onto opiates in particular.
Dr John Dickson, steering committee member of the Primary Care Rheumatology Society and a former GP in Middlesborough, said NICE had ‘dodged’ the issue.
He said: ‘The only thing they’ve said is to be careful when routinely using paracetamol – they feel that advice should go out. But the final guidance does not include the explanation for that.’
Dr Dickson said the US Food and Drug Administration had placed tighter restrictions on paracetamol in recent years over liver toxicity concerns, and there should be a better co-ordination between the different regulatory agencies including the European Medicines Agency, the MHRA and NICE – and called for an independently funded study of paracetamol to clarify its safety.
He said: ‘These bodies don’t work together properly – the FDA, the EMA and MHRA should say we are all concerned, let’s fund a decent study.’
NICE refused to comment on the leaked draft, but said the final guidance would be published tomorrow.
Dr Bill Beeby, deputy chair of the GPC clinical and prescribing subcommittee, welcomed NICE’s change of approach to paracetamol.
Dr Beeby said: ‘News that NICE has not decided to rule against the use of paracetamol in the routine management of osteoarthritis is most welcome. For many patients it does provide a degree of relief and though the MHRA safety review might demonstrate some issues that will need future considerations, I am sure that the relative risks of paracetamol when compared to other analgesic choices (both over the counter and prescribed) will be favourable.’