- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Dentistry, Pain management and palliation, and Rheumatology
New recommenedations after a Europe-wide review of cardiovascular safety.
Article date: June 2013
An increased risk of heart attack and stroke with some non-selective non-steroidal anti-inflammatory drugs (NSAIDs)—such as diclofenac—is well recognised, particularly with long-term use of high doses and in patients who are already at high risk. Warnings for healthcare professionals and patients have been included in the product information and in the British National Formulary for some years.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has recently recommended updates to the treatment advice for diclofenac in light of the findings of a Europe-wide review of the cardiovascular safety of NSAIDs. The review found further evidence that the arterial thrombotic risk with diclofenac is similar to that for the selective COX-2 inhibitors.
The new treatment advice applies to systemic formulations (ie, tablets, capsules, suppositories, and injection available both on prescription and via a pharmacy, P); it does not apply to topical (ie, gel or cream) formulations of diclofenac.
A recently published meta-analysis 1 of clinical trial data provides further evidence that the arterial thrombotic risk with diclofenac is similar to that of COX-2 inhibitors. This analysis found that of 1000 patients allocated to diclofenac for a year, three more had major vascular events, compared with placebo.
Advice for healthcare professionals
New advice for diclofenac:
- diclofenac 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)
Patients with these conditions should be switched to an alternative treatment at their next routine appointment.
Diclofenac treatment should only be initiated after careful consideration for patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Reminder of existing advice for all NSAIDs
The decision to prescribe an NSAID should be based on an assessment of a patient’s individual risk factors, including any history of cardiovascular and gastrointestinal illness.
Naproxen and low-dose ibuprofen are considered to have the most favourable thrombotic cardiovascular safety profiles of all non-selective NSAID.
The lowest effective dose should be used for the shortest duration necessary to control symptoms. A patient’s need for symptomatic relief and response to treatment should be re-evaluated periodically.
Additional advice for pharmacists
Update: oral diclofenac is no longer available without a prescription. Therefore this advice for pharmacists is out-dated.
Non-prescription availablility of diclofenac
Diclofenac is available to buy in a pharmacy without a prescription at low doses (up to 75 mg/day) for short-term use (3 days). Pharmacists are asked to take the following steps when supplying diclofenac without prescription:
- ask questions to exclude supply for use by people with established cardiovascular disease and people with significant risk factors for cardiovascular events
- advise patients to take diclofenac only for 3 days before seeking medical advice
- advise patients to take only one NSAID at a time
This information will be circulated via the NHS Central Alerting System in early July.
European Medicines Agency statement
Reminder of existing advice:
European Medicines Agency public assessment report, October 2012
General NSAID advice
Article citation: Drug Safety Update vol 6, issue 11 June 2013: A2.