The European Medicines Agency has completed a review of diclofenac. A positive benefit-risk balance has been confirmed but new contraindications and revised warnings have been recommended.
The review was started in October 2012 in response to a broader review of NSAIDs which identified a small increase in the risk of cardiovascular side effects with diclofenac compared with other drugs in the class. This more recent review has concluded that diclofenac increases the number of heart attacks by approximately 3 cases per year for every 1,000 people treated who are at moderate cardiovascular risk.
As such it is now recommended that, "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". It is also suggested that patients with an underlying heart condition who are currently taking diclofenac should speak to their GP or pharmacist at their next routine visit to consider alternative treatments.
Action: Clinicians should be aware of this review and the new advice. Non-NSAID options should be considered where possible. Where an NSAID is required the lowest effective dose should be used for the shortest possible duration.