The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has recommended that patients with serious underlying heart conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke should not use diclofenac. This is due to 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: “For many patients diclofenac will continue to provide safe and effective pain relief but is no longer suitable for certain at risk groups. This is a known risk and warnings have been included in patient and healthcare information for some time and are now being updated. 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.”
UK MHRA will be shortly issuing updated information to patients and healthcare professionals.