- Medicines and Healthcare products Regulatory Agency
- 22 January 2015
- Therapeutic area:
- Pain management and palliation and Rheumatology
Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
When using aceclofenac to relieve pain and inflammation in osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, you should:
- consider that aceclofenac is now contraindicated in patients with established:
- ischaemic heart disease
- peripheral arterial disease
- cerebrovascular disease
- congestive heart failure (New York Heart Association, NYHA, classification II-IV)
- switch patients with these conditions to an alternative treatment at their next routine appointment
- only start aceclofenac treatment after careful consideration of any significant risk factors for cardiovascular events, eg
- diabetes mellitus
Aceclofenac (Preservex) is a non-steroidal anti-inflammatory drug (NSAID) licensed for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Aceclofenac has little pharmacological activity itself; its main mode of action is through its metabolites which include diclofenac and 4’-hydroxy diclofenac.
In June 2013 we told you about the new contraindications and warnings for diclofenac. This was after a review by European regulators concluded that the risk of arterial thrombotic events (myocardial infarction; stroke) with diclofenac is greater than with other non-selective NSAIDs and similar to the COX-2 inhibitors.
There are limited data available regarding the arterial thrombotic effects of aceclofenac. The treatment advice for aceclofenac has been updated in line with diclofenac and COX-2 inhibitors. This was based on aceclofenac’s structural similarity to diclofenac and its metabolism to diclofenac.
Reminder of advice for all NSAIDs
Base the decision to prescribe an NSAID on an assessment of each patient’s individual risk factors including any history of cardiovascular and gastrointestinal illness.
Use the lowest effective dose for the shortest duration necessary to control symptoms. Periodically re-evaluate the patient’s need for symptomatic relief and response to treatment.
Article citation: Drug Safety Update volume 8 issue 6 January 2015: 5
Published: 22 January 2015