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Drugs regulator puts tighter restrictions on diclofenac use

GPs should no longer prescribe diclofenac to patients with established cardiovascular disease under any circumstances, the European Medicines Agency (EMA) has ruled.

Use of diclofenac is now contraindicated in patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, whereas previously it could be used with caution in these groups.

This means the restriction on diclofenac is now on a par with that of selective COX-2 inhibitors such as etoricoxib.

The EMA also says GPs should only use the NSAID in patients with cardiovascular risk factors ‘after careful consideration’ and that it should always be used at the lowest dose and for the shortest duration possible. GPs are advised to review all patients using the drug regularly at the next scheduled appointment.

The decision comes after an EMA review of the atherothrombotic risk associated with diclofenac requested by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Dr Sarah Branch, deputy director of the MHRA’s Vigilance and Risk Management of Medicines Division said: ‘Whilst this is a known risk and warnings have been included in patient and healthcare information for some time, this advice is now being updated. For many patients diclofenac will continue to provide safe and effective pain relief but is no longer suitable for certain at risk groups

‘Those with underlying heart conditions currently taking diclofenac should speak to their GP or pharmacist at their next routine visit to consider an alternative pain relief treatment.

‘Patients with certain cardiovascular risk factors such as high blood pressure, raised cholesterol, diabetes and smoking should only use diclofenac after careful consideration with their GP or pharmacist.’

European Medicines Agency – new safety advice for diclofenac


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