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MHRA to review anticoagulant prescribing after CKD stroke risk warning

The Medicines and Healthcare Products Regulatory Agency has said it will review the use of anticoagulants, following a new study which showed increased risks for chronic kidney disease patients.

Both the MHRA and NICE have now responded to the findings, with the regulatory agency confirming that they are reviewing the situation to determine if there are any safety implications for patients. 

The study, which showed that CKD patients taking anticoagulants were nearly three times more likely to experience a stroke and more than twice as likely to suffer a haemorrhage, was published last week in the BMJ

In their current advice, the MHRA has said that GPs should take 'special care' when prescribing new oral anticoagulants to patients with other conditions, and should pay particular attention to renal function.

A spokesperson for the agency which licences the drugs, said: ‘Patient safety is our highest priority and as with all medicines, the safety of blood thinners is kept under constant review.

‘The MHRA is aware of the new study on the use of blood thinners in patients with kidney disease and will review the findings to determine whether they have any implications for the safe use of these medicines.

‘Any patient who is concerned about their treatment with blood thinners should contact their doctor but continue to take their medicine in the meantime.’

NICE also has guidance on the use of anticoagulation medication and has recommended their use in some patients with atrial fibrillation.

A NICE spokesperson said: ‘As with all our clinical guidelines, our guideline on the management of AF assumes that prescribers will use a drug's summary of product characteristics to inform decisions made with individual patients.

‘We are currently updating our guideline on the management of AF and will consider the study and any resulting action from MHRA in relation to anticoagulants to prevent strokes in people with AF as part of that process.’

GPs have previously been warned about prescribing anticoagulants to at-risk patients, due to potential adverse events such as an increased risk of bleeding.

This was the result of a study published last June, which found that patients with AF and contraindications to anticoagulants were still just as likely to be prescribed the medication as those without risk factors. It suggested that 38,000 at-risk AF patients were being treated with anticoagulants across the UK.

RCGP chair Professor Helen Stokes-Lampard commented: ‘As our patients become older, they inevitably live with more – often multiple – long term conditions. Ensuring they have the most appropriate treatment, considering any potential interactions between conditions, and medication they might be taking, is a huge challenge for GPs and other prescribers.

‘It is important that as new research is published that it is taken into account as clinical guidelines are developed and updated. We’re pleased that anonymised patient data collected by the RCGP’s Research Surveillance Centre is being used to inform high-quality research that might improve the care we give to our patients, in the best interests of their long-term health and wellbeing.’

Readers' comments (7)

  • time to send all anticoagulation prescribing back to secondary care

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  • Did MHRA really say "blood thinners"? - an historical term we used to use as a short hand explanation for patients but not clinically accurate. MHRA should know better and not perpetuate the use of this term.

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  • Rogue1

    As this was between 2004 and 2015, I take it most of this is in relation to Warfarin? The NOAC have come in more recently but they have dosing limits for CKD, unless they are saying that those limits are actually inaccurate?

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  • NOACs are a disaster waiting to happen. Spoke to a medical consultant who has seen a big rise in litigation cases due to Gps not monitoring properly. It is complex and confusing with various levels for different blood tests etc

    Secondary care are handing them out like smarties - with very pushy drug reps

    There is no shared care agreement in our area and was handed abor as being easier than warfarin but the monitoring required is confusing and complex - maybe somethignthe BMA can take up

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  • Well happy being a dinosaur. Personal experience with DVT and opted for LMWH + Warfarin.

    Some inter-consultant discussion/suggestion following on from this as to whether, after this 1 specific event, I should be on long-term NOAC

    Not for me and 50% yellow card rate on the 8 from last year says it all.

    PS how do you monitor time in therapeutic index with NOAC?

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  • Cobblers

    Plasma drug concentrations, ecarin clotting time, dilute thrombin time, and anti-FXa levels appear useful to monitor DOAC intensity, but are these available in the NHS?

    Or does the litigation refer to warfarin?

    IMHO the warfarin DES needs to be junked and handed back to the secondary sector. Along with warfarin prescribing.

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  • The study looked at eGFRs under 50, they need to be clearer which “CKD” patients they mean. Presumably CKD3 with eGFR 50-60 should still be treated with anticoagulant? Does ACR need taking into account? I hope a NICE bring some clarity, and soon!

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