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Press release: MHRA confirms advice on the use of diclofenac

Press release

Date: 28 June 2013
Time: 13:00
Subject: MHRA confirms advice on the use of diclofenac
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

Patients with serious underlying heart conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke should no longer use diclofenac, the MHRA confirmed today.

This follows completion of a European review which found a small increased risk of heart attack and stroke.

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.”

Notes to Editor

  1. Diclofenac is a type of non-steroidal anti-inflammatory drug (or ‘NSAID’).  Anti-inflammatory drugs are widely used important medicines in the treatment of arthritis and many other painful conditions, including headache, fever and minor ailments.  Diclofenac, along with ibuprofen and naproxen, is among the most widely used anti-inflammatory medicines in the UK
  2. Drug Safety Update: Volume 6, Issue 11 June 2013
  3. Link to EMA press release (external link)
  4. The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.
Page last modified: 28 June 2013