The world's most commonly used painkiller may significantly increase the risk for cardiovascular events such as heart attack and stroke, findings of a new study published in the British Medical Journal have shown.


Diclofenac is used for treating pain and inflammation. Although it is not well-known it the United States, it is the most widely used non-steroidal anti-inflammatory drug or NSAID in the world. It is available as a prescription and over-the-counter medication under brands that include Zorvolex, Voltaren, Cambia, and Solaraze.

Study researcher Morten Schmidt, from Aarhus University Hospital, and colleagues looked at the medical records of over 6 million adults in Denmark spanning the period between 1996 and 2016.

Increased Rate Of Cardiovascular And Gastrointestinal Events

The researchers found that starting diclofenac during the study period was linked to increased rate of cardiovascular events such as heart failure, heart attack, irregular heartbeat, and ischaemic stroke within a month compared with starting paracetamol, or other traditional NSAIDs such as ibuprofen or naproxen.

A 2017 study showed that the risk of heart among those who use NSAIDs is more pronounced when the drug is taken in high daily doses.

Schmidt and colleagues also found that starting diclofenac was linked to the elevated rate of cardiac death compared with no NSAIDS.

Those who started used diclofenac were likewise found to have a higher risk of upper gastrointestinal bleeding than those who started ibuprofen or paracetamol, and those who did not take NSAIDs.

Warning To Potential Users

The findings suggest that that the drug diclofenac should not be made available as an over-the-counter drug. Researchers also said that the drug should come with an appropriate front package warning to inform users of its potential health risks.

The researchers said that despite the potential side effects, treatment with NSAIDs may be worthwhile for improving the quality of life of patients suffering from pain and inflammation. The gastrointestinal and cardiovascular risks associated with the treatment, however, does not justify initiating diclofenac treatment before other traditional NSAIDs.

"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 Sept. 4. "In conclusion, our data support that initiation of diclofenac poses a cardiovascular health risk, both compared with no use, paracetamol use, and use of other traditional NSAIDs."

Schmidt and colleague said that their study was observational, which does not necessarily prove a causal association. However, they noted that the sample size was larger compared with earlier analyses.

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