Drugs Xagena
Available data indicate that the cardiovascular risk with Diclofenac is similar to that of the selective COX-2 inhibitors. Consistent with COX-2 inhibitors, Diclofenac is now contraindicated in those with: ischaemic heart disease; peripheral arterial disease; cerebrovascular disease; or established congestive heart failure ( New York Heart Association [ NYHA ] classification II–IV ).
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.
An increased risk of myocardial infarction 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.
A recently published meta-analysis 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
News 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 NSAIDs.
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. ( Xagena )
Source: Drug Safety Update 2013 vol 6, issue 11: A2
XagenaMedicine_2013
