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Call for diclofenac ban rejected

Calls to ban the NSAID diclofenac because of its higher cardiovascular risk have been rejected as an overreaction by GPs and rheumatology experts.

The call comes after a review by UK and Canadian researchers showed diclofenac is still the most widely prescribed NSAID despite its cardiovascular adverse effects which the researchers say are similar in magnitude to those of other drugs, such as the now withdrawn rofecoxib.

The study in PLOS Medicine found that diclofenac accounted for about 30% of NSAID prescriptions in the UK, putting it ahead of alternatives such as naproxen (26%) and ibuprofen (24%).

The researchers said their findings ‘demonstrate that evidence about the risks associated with diclofenac has translated poorly to clinical practice’.

Study lead Dr Patricia McGettigan, senior lecturer in clinical pharmacology at Barts and The London School of Medicine and Dentistry, said diclofenac had no advantage over alternatives such as naproxen in terms of efficacy or gastrointestinal safety ‘and it has a clear cardiovascular disadvantage’.

‘There are strong arguments to revoke its marketing authorisations globally,’ she writes in PLOS Medicine.

However, Dr Louise Warburton, a GP in Shropshire and president of the Primary Care Rheumatology Society opposed the call for diclofenac to be withdrawn, saying GPs were already aware of its cardiovascular risks and would prescribe it with caution.

She told Pulse: ‘I don’t think it should be completely withdrawn, that would be too strong.

‘We’re already well aware of the increased cardiac risk [with diclofenac]. In the area where I work  we were advised some years ago by the PCT not to prescribe diclofenac but to use naproxen instead, for this reason.

‘Some patients still ask for diclofenac and I would be happy to prescribe it if they are aware of the risk.’

Consultant rheumatologist Dr Robert Thompson of the British Society for Rheumatology also rejected the idea of banning diclofenac, saying it was still a very useful drug if used with regard to overall benefit and risk.

He said: ‘The key message is risk stratification. Cardiovascular risk applies across all NSAIDs and if a patient is considered at risk for diclofenac then perhaps they shouldn’t be on an NSAID at all.’

The Medicines and Healthcare products Regulatory Agency said that the evidence for diclofenac suggests that it has a thrombotic risk profile similar to that of the COX-2 inhibitors. The MHRA says a decision on whether to review the treatment advice for diclofenac is being considered by the European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee.

A spokesperson said: ‘In the meantime diclofenac should be prescribed in accordance with the known risks and at the lowest effective dose for the shortest possible time.’

Readers' comments (3)

  • Vinci Ho

    It is all time about whether you can share this concept of benefit against risk with your patient . No doubt , oral diclofenac works for certain patients more than other NSAIDs , whether it is genetically determined or not.
    Total ban will then take away their chance of controlling pain and compromise quality of life.......

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  • I dont agree with you Vinci. We have changed all but a handful of our patients over to Naproxen/Ibuprofen with little effort or complaint. Our ongoing issue is with Orthopods who still use it as first line treatment and this invariably results in a clash with patients when we suggest changing it.

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  • Dear All,
    What is the EVIDENCE?

    its as follows;

    at doses OVER 150mg daily there is an increase in thrombotic events from Diclofenac from 0.8% to about 1.2%.

    below this daily dose there in NO increased risk.

    at normal doses Naproxen has a higher non thrombotic complication rate.

    Naproxen is more expensive.

    The evidence based decision is to use diclofenac.

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