Painkiller Linked to Increased Risk of Major Heart Problems

Frederick Owens
September 9, 2018

Diclofenac, a widely used global drug with anti-inflammatory and analgesic properties, is associated with an increased risk of heart attack, stroke and other serious cardiovascular problems, so its use should be done with moderation rather than for a long time. "Considering its cardiovascular and gastrointestinal risks, however, there is little justification to initiate diclofenac treatment before other traditional NSAIDs", they conclude.

Dr Schmidt's team found in the study - published in the British Medical Journal - that patients using the drug were more likely to suffer heart problems.

But its cardiovascular risks compared with those of other traditional NSAIDs have never been examined in large randomized controlled trials, and current concerns about these risks make such trials unethical to conduct.

Diclofenac is a traditional non-steroidal anti-inflammatory drug (NSAID) for treating pain and inflammation and is widely used across the world.

The researchers reviewed the data of more than 6.3 million adults in Denmark which used either diclofenac or paracetamol to treat inflammation and pain. The first negative effects noticed after a month of use, patients began to complain of pain in the heart, not seen them earlier. When it is prescribed it "should be accompanied by an appropriate front package warning about its potential risks".

Specifically, the risk of such adverse cardiovascular events was 50 percent higher among those who started taking diclofenac, compared with those who did not take it.

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To investigate any link between diclofenac and potential cardiovascular health risks the Aarhus University Hospital researchers turned to data in the Danish National Patient Registry and the Danish National Prescription Registry to identify a study population, health outcomes, and drug use. The overall risk for each individual patient, though, was found to be low.

The adverse event rate among diclofenac initiators increased 50 percent compared with non-medication users, 20 percent compared with paracetamol or ibuprofen initiators and 30 percent compared with naproxen initiators.

This is an observational study, so no firm conclusions can be drawn about cause and effect.

But the study's sample size is larger than most previous analyses of observational and randomised studies taken together and provides strong evidence to guide clinical decision making. The problems included cardiac arrhythmia, heart failure, ischemic stroke, stroke, premature death of cardiovascular disease and gastrointestinal haemorrhage.

"It is time to acknowledge the potential health risk of diclofenac and to reduce its use", Schmidt and colleagues wrote in their study, which was published on September 4.

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