MHRA specifies that patients with circulatory problems, heart disease, heart failure, or a previous stroke or heart attack should stop using diclofenac.
Diclofenac is known under several trade names, including Diclomax, Defenac, Diclofex, Dyloject, Econac, Enstar, Flamrase, Flamatak, Motifene, Rheumatac, Rhumalgan, Volsaid, and Voltarol.
Diclofenac is an NSAID (non-steroidal anti-inflammatory drug), and is used for the treatment of painful conditions, including dental pain, migraine, gout, sprains and strains, arthritis, and pain after surgical procedures. Diclofenac alleviates pain and lowers inflammation.
Diclofenac, naproxen and ibuprofen are the most commonly used anti-inflammatory medications in the United Kingdom.
MHRA says its warning follows a European review of Diclofenac which identified a slight increase in the risk of stroke and heart attack.
Deputy Director of the MHRA's Vigilance and Risk Management of Medicines Division, Dr. Sarah Branch, 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."
The MHRA added that the new treatment advice applies to systemic formulations, including capsules, tablets, suppositories, and injection. It does not apply to topical formulations of Diclofenac (gels or creams).
MHRA's new advice to doctors regarding diclofenac
- Diclofenac is now contraindicated for patients diagnosed with:
- cerebrovascular disease
- congestive heart failure (New York Heart Association [NYHA] classification II-IV)
- ischaemic heart disease
- peripheral arterial disease
At their next routine appointment, patients with these conditions should be offered alternative treatment.
- "Diclofenac treatment should only be initiated after careful consideration for patients with significant risk factors for cardiovascular events", including high blood pressure (hypertension), diabetes mellitus, smoking, hyperlipidemia.
MHRA's new advice to pharmacists regarding diclofenacDiclofenac can be purchased as an OTC (over-the-counter) medication at the pharmacy without a prescription at low doses (≤75 mg/day) for short-term use (up to 3 days).
When supplying OTC diclofenac, pharmacists should:
- Check whether the customer has established cardiovascular disease or significant risk factors for cardiovascular events. If they do, exclude the supply (do not give it to them).
- Tell customers that OTC diclofenac is to be used for up to three consecutive days only - they should check with their doctors for longer periods.
- Tell customers that NSAIDs must be taken only one at a time.
Diclofenac is commonly used worldwideA study published in PLoS (February 2013 issue) found that diclofenac is the most commonly used NSAID in the 15 countries studied. The authors added that Diclofenac was listed in the essential medicines list of 74 nations, while naproxen (which is much safer) in just 27 countries.
An article published in the journal Circulation (May 2011 issue) revealed that diclofenac users were three times more likely to die or have a repeat heart attack within one week of use
Written by Christian Nordqvist