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More clear warnings should be given about the risks of diclofenac, say researchers who found a higher risk of heart attack and stroke associated with its use.
Researchers used Danish national registry data for more than 6.3 million adults over a ten-year period to emulate clinical trial conditions to test the risk of diclofenac against other painkillers.
They found that the widely used painkiller was associated with an increased risk of major adverse cardiovascular events in the first 30 days of use when compared with ibuprofen, naproxen and paracetamol.
The risk was apparent for both men and women of all ages and with low doses of diclofenac, the study in the BMJ reported.
It was also found to be linked to an increased risk of cardiac death when compared with taking no traditional non-steroidal anti-inflammatory drugs (NSAIDs).
For those with the lowest baseline risk, starting diclofenac was associated with one extra event per 1000 patients per year, compared with those starting ibuprofen or naproxen; three extra events compared with those starting paracetamol; and four extra events compared with those taking no NSAIDs.
For those at moderate risk at the start, they found 7 extra cardiovascular events with diclofenac compared with ibuprofen or naproxen; 8 extra events compared with paracetamol; and 14 extra events compared with no NSAIDs.
The additional cardiovascular events increased further in the high-risk group, with extra cardiovascular events seen in 39 out of 1000 patients per year, compared with no NSAIDs.
The researchers concluded that diclofenac should not be available over the counter and, when prescribed, should be accompanied by an appropriate package warnings about its potential risks.
“It is time to acknowledge the potential health risk of diclofenac and reduce its use,” they wrote.
And while treatment of pain and inflammation with NSAIDs may be worthwhile for some patients, they concluded: “Considering its cardiovascular and gastrointestinal risks, however, there is little justification to initiate diclofenac treatment before other traditional NSAIDs.”
