Diclofenac safety changes
Anti-inflammatory painkiller no longer suitable for certain at risk groups.
17th June 2013 - The European Medicines Agency has recommended that patients with serious underlying heart conditions should not use the painkiller diclofenac due to a small increased risk of heart attack and stroke.
People with underlying heart conditions currently taking the medicine should speak to their GP or pharmacist at their next routine visit to consider an alternative pain relief treatment.
The recommendation follows a review of diclofenac initiated in October 2012 by the UK medicines agency.
Diclofenac is a widely used medicine for relieving pain and inflammation, particularly in conditions such as arthritis. It belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’ ( NSAIDs). It has been available for many years under a wide range of trade names and comes in capsules, tablets, suppositories and injections.
Diclofenac is available on prescription. You can also buy a short course of diclofenac potassium at pharmacies, without a prescription, for pain such as headache, dental pain, period pain, backache and symptoms of cold and flu.
The EMA recommendation states that patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke, should not use diclofenac. Patients with certain cardiovascular risk factors (such as high blood pressure, raised blood cholesterol, diabetes or smoking) should only use diclofenac after careful consideration.
Dr. Sarah Branch from the MHRA which regulates medicines in the UK says in a press release: "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."