Patients with serious underlying heart conditions and those who have suffered a heart attack or stroke should not be given the NSAID diclofenac, the MHRA has warned.

The guidance, issued today (June 28), follows a review by the European Medicines Agency (EMA) last year, which found a small increased risk of heart attack and stroke among those taking the drug.

When supplying diclofenac over the counter, pharmacists should identify patients that have or are at risk of cardiovascular disease, and should advise them customers to only take the treatment for three days before seeking medical advice, the MHRA said.

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	Pharmacists should also warn patients to only take one NSAID at a time, the medicines watchdog said.

Diclofenac was the most commonly prescribed NSAID across 15 countries, including England, despite having the highest risk of side effects, a study published in the journal Plos in February found.

The study called for the removal of diclofenac from the 74 essential medicines lists it appeared in worldwide, and the Royal Pharmaceutical Society (RPS) told C+D at the time that the significant use of diclofenac in England needed to be addressed by pharmacists. 

MHRA deputy director of vigilance and risk management of medicines Sarah Branch has now advised that patients with underlying heart conditions should speak to their pharmacist or GP at their next routine visit to discuss alternative pain relief.

Dr Branch said 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".

However, it would continue to remain an effective and safe pain relief for many patients, she said. The MHRA's advice applies to systemic formulations, but does not apply to topical formulations.

The review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) was undertaken last October after a request from the MHRA.

The recommendations were endorsed today (June 28) by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which is responsible for ensuring harmonised safety standards across the EU.

Although there has been a slow decline in prescriptions for diclofenac in England since 2006, almost 5 million items were prescribed in 2011, according to recent NHS figures.

The MHRA and EMA advice

Information to patients

• Overall, the benefits of this medicine are greater than its risks, but there is a small risk of heart attack or stroke in patients taking systemic diclofenac regularly, especially at high doses (150mg daily) and for long periods. If 1,000 patients at moderate risk took diclofenac for a year, there would be about three extra cases of heart attack among them, compared with patients not taking diclofenac.  
• The risk with diclofenac is increased more if you are already at higher risk, so use is no longer recommended if you have already had a heart attack or stroke, or have heart failure, blockages to blood vessels to the heart or brain or an operation to clear or bypass such blockages, or circulatory problems that restrict blood flow to your limbs.  
• If you have other risk factors such as high blood pressure, high blood cholesterol, diabetes, or if you smoke, your doctor will need to assess if you should use diclofenac and the best way to take it.  
• If you are on long-term diclofenac treatment you will need to have your treatment reviewed to ensure that it is still right for you. Speak to your prescriber at your next scheduled appointment.  
• You should not stop taking your treatment without talking to your doctor.  
• If you have any questions, speak with your doctor or pharmacist.

Information to healthcare professionals

• Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long-term treatment.  
• Use of diclofenac is contra-indicated in patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.  
• Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.  
• As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.  
• In the light of the above, all patients receiving regular diclofenac therapy should be reviewed at the next scheduled appointment.

Additional advice for pharmacists: non-prescription availability of diclofenac

Diclofenac is available to buy in a pharmacy without a prescription at low doses (up to 75mg/day) for short-term use (three days). Pharmacists are asked to take the following steps when supplying diclofenac without prescription:

• ask questions to exclude supply for use by people with established cardiovascular disease and people with significant risk factors for cardiovascular events

• advise patients to take diclofenac only for three days before seeking medical advice

• advise patients to take only one NSAID at a time.

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