Diclofenac cardiovascular warnings and contraindications updated

Recent cardiovascular safety concerns have led the MHRA to issue new prescribing advice for systemic formulations of diclofenac.

The long-term use of high doses of NSAIDs is associated with an increased risk of MI and CVA | SCIENCE PHOTO LIBRARY
The long-term use of high doses of NSAIDs is associated with an increased risk of MI and CVA | SCIENCE PHOTO LIBRARY

The Agency cited a recently published meta-analysis that provided further evidence of an increased risk of arterial thrombosis with diclofenac, similar to that observed with COX-2 inhibitors.

New contraindications

The use of diclofenac is now contraindicated in patients with:

  • ischaemic heart disease
  • peripheral arterial disease
  • cerebrovascular disease
  • congestive heart failure

Patients with any of these conditions who are currently receiving diclofenac should be switched to an alternative treatment at their next appointment.

Use with caution when cardiovascular risk factors present

In addition, caution should be used when prescribing diclofenac in patients with significant risk factors for cardiovascular events, such as hypertension, hyperlipidaemia, diabetes mellitus and smoking.

These new contraindications and warnings apply to systemic formulations of diclofenac (tablets, capsules, suppositories and injections) but not topical products (creams and gels).

View diclofenac drug records

MHRA Drug Safety Update June 2013 

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