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‘Little justification’ for prescribing diclofenac, researchers warn

There is ‘little justification’ for prescribing diclofenac given its cardiovascular and gastrointestinal risks when compared to other NSAIDs, researchers have warned.

A study carried out by researchers in Denmark looked at almost 1,400,000 patients who were started on diclofenac between 1996 and 2016, as well as patients who were initiated on other types of NSAIDs and patients who weren’t initiated on any NSAIDs.

The researchers advised that diclofenac should come with front of package warnings about its risks after the study found that patients who started diclofenac were at a 50% increased risk of cardiovascular events - such as heart failure, heart attack or atrial fibrillation - in the 30 days after starting the drug compared with those not taking the drug.

Diclofenac initiators were also at 20% increased risk compared to patients taking ibuprofen or paracetamol, and at 30% increased risk compared to those taking naproxen. These risks remained regardless of the diclofenac dose.

The risk of gastrointestinal bleeding at 30 days increased 4.5-fold in patients who started diclofenac compared to those who didn’t.

The researchers said that given the risks, doctors should be initiating treatment where indicated with other types of NSAIDs before considering diclofenac.

They said in the paper: ‘Treatment of pain and inflammation with NSAIDs may be worthwhile for some patients to improve quality of life despite potential side effects. Considering its cardiovascular and gastrointestinal risks, however, there is little justification to initiate diclofenac treatment before other traditional NSAIDs.

‘It is time to acknowledge the potential health risk of diclofenac and to reduce its use. Diclofenac should not be available over the counter, and when prescribed, should be accompanied by an appropriate front package warning about its potential risks.’

Diclofenac was made prescription-only in 2015 due to its associated ‘small risk’ with heart problems.

BMJ 2018; available online 4 Septemeber