Diclofenac: new contraindications and warnings


Article date: June 2013

An elevated threat of coronary heart assault and stroke with some non-selective non-steroidal anti-inflammatory medicine (NSAIDs)—comparable to diclofenac—is effectively recognised, notably with long-term use of excessive doses and in sufferers who’re already at excessive threat. Warnings for healthcare professionals and sufferers have been included within the product info and within the British Nationwide Formulary for some years.

The European Medicines Company’s Pharmacovigilance Danger Evaluation Committee has just lately beneficial updates to the therapy recommendation for diclofenac in gentle of the findings of a Europe-wide assessment of the cardiovascular security of NSAIDs. The assessment discovered additional proof that the arterial thrombotic threat with diclofenac is much like that for the selective COX-2 inhibitors.

The brand new therapy recommendation applies to systemic formulations (ie, tablets, capsules, suppositories, and injection accessible each on prescription and through a pharmacy; P); it doesn’t apply to topical (ie, gel or cream) formulations of diclofenac.

A just lately revealed meta-analysis of medical trial information supplies additional proof that the arterial thrombotic threat with diclofenac is much like that of COX-2 inhibitors. This evaluation discovered that of 1000 sufferers allotted to diclofenac for a yr, three extra had main vascular occasions, in contrast with placebo.

Recommendation for healthcare professionals

New recommendation for diclofenac:

  • diclofenac is now contraindicated in sufferers with established:
    • ischaemic coronary heart illness
    • peripheral arterial illness
    • cerebrovascular illness
    • congestive coronary heart failure (New York Coronary heart Affiliation [NYHA] classification II–IV)

Sufferers with these situations ought to be switched to an alternate therapy at their subsequent routine appointment.

Diclofenac therapy ought to solely be initiated after cautious consideration for sufferers with vital threat elements for cardiovascular occasions (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Reminder of present recommendation for all NSAIDs

The choice to prescribe an NSAID ought to be primarily based on an evaluation of a affected person’s particular person threat elements, together with any historical past of cardiovascular and gastrointestinal sickness.

Naproxen and low-dose ibuprofen are thought-about to have probably the most beneficial thrombotic cardiovascular security profiles of all non-selective NSAID.

The bottom efficient dose ought to be used for the shortest period needed to regulate signs. A affected person’s want for symptomatic reduction and response to therapy ought to be re-evaluated periodically.

Extra recommendation for pharmacists

Non-prescription availablility of diclofenac

Diclofenac is in the stores in a pharmacy and not using a prescription at low doses (as much as 75 mg/day) for short-term use (3 days). Pharmacists are requested to take the next steps when supplying diclofenac with out prescription:

  • ask inquiries to exclude provide to be used by individuals with established heart problems and other people with vital threat elements for cardiovascular occasions
  • advise sufferers to take diclofenac just for 3 days earlier than in search of medical recommendation
  • advise sufferers to take just one NSAID at a time

This info might be circulated through the NHS Central Alerting System in early July.

Additional info

New recommendation

Message despatched through the NHS Central Alerting System, together with materials to move on to sufferers

European Medicines Company assertion

Reminder of present recommendation:

European Medicines Company public evaluation report, October 2012

Earlier NSAID recommendation from Drug Security Replace (October 2012, February 2009, December 2007)

Basic NSAID recommendation

MHRA web site info on NSAIDs

British Nationwide Formulary

Scientific Data Summaries on NSAID prescribing

Article quotation: Drug Security Replace vol 6, subject 11 June 2013: A2.


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