- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Pain management and palliation and Rheumatology
Further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
Article date: October 2012
A new review on the cardiovascular safety of NSAIDs has highlighted further evidence that diclofenac is associated with cardiovascular risks that are higher than the other non-selective NSAIDs, and similar to the selective COX-2 inhibitors. Naproxen and low-dose ibuprofen are still considered to have the most favourable cardiovascular safety profiles of all non-selective NSAIDs.
This review, by the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP), evaluated all available data on this issue since the last review conducted in 2006.
The findings highlighted in this review are not new; an increase in risk of heart attack and stroke with some non-selective NSAIDs, such as diclofenac, particularly with long-term use of high doses and in patients who are already at high risk, is well recognised. Warnings have been included in the product information for healthcare professionals and patients, and in the BNF, for some years.
The need for any update to the existing treatment advice for diclofenac will now be assessed by the European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC).
Healthcare professionals are reminded that, when prescribing NSAIDs, patients should use the lowest effective dose for the shortest time necessary to control symptoms. The patient’s individual risk factors, including any history of cardiovascular and gastrointestinal illness, should also be taken into account.
Press release from the European Medicines Agency website
Previous advice on NSAIDs from Drug Safety Update February 2009 andDecember 2007
MHRA webpage on the cardiovascular safety of NSAIDs
BNF section 10.1 Drugs used in rheumatic diseases and gout
Article citation: Drug Safety Update October 2012, vol 6, issue 3: S1.