Common painkiller linked to major heart problems

Heart concerns led to British regulators banning the drug over-the-counter in 2015 but authors of the study published today in the British Medical Journal are calling for global action

Researchers explained that irregular heart beats, heart flutters, ischaemic stroke, heart failure and heart attacks were potential cardiovascular events that could occur when taking Diclofenac. use of the drug was also linked to an increased rate of cardiac death compared to other non-steroidal anti-inflammatory painkillers.

They examined the cardiovascular risks of starting diclofenac compared with no NSAIDS, starting other traditional NSAIDs and paracetamol. Scientists came to the conclusion that Diclofenac has a direct impact on the education of cardiovascular diseases, including ischemic stroke, arrhythmia, heart attack and others.

As it is used mostly to treat inflammations and pains, diclofenac, which is a non-steroidal anti-inflammatory drug, also known as NSAID, is broadly consumed all over the world.

To conduct this study, the researchers utilized the national registry data containing details on the 6.3 million adults residing in Denmark. Current concerns about the cardiovascular safety of NSAID use mean that such a trial would now be unethical, but regulators including the European Medicines Agency are still calling for the safety of diclofenac to be assessed.

Researchers found that the increased risks applied to men and women of all ages and also those taking low doses of diclofenac.

They suggested diclofenac be prescribed with a warning label attached and banned as an over-the-counter drug in countries like the USA where it's available as such.

The findings prompted researchers to say that diclofenac should not be available over the counter, and when prescribed, should be accompanied by an appropriate front package warning about its potential risks. The risk of upper gastrointestinal bleeding at 30 days of diclofenac use was similar to that associated with naproxen, but was 4.5-fold higher than it was among patients who didn't take NSAIDs and 2.5-fold higher than for paracetamol, or ibuprofen initiators. The risks were evident whether the participants took high, or low doses of the drug.

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The authors point out that, although the relative risk was increased, the absolute risk remained low for the individual patient.

The study also relies on observational data, so it can't directly prove that diclofenac is causing problems.

However, 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.

People who have suffered heart failure, heart disease or a stroke should stop using it completely.

"It is time to acknowledge the potential health risk of diclofenac and to reduce its use", the authors wrote.

"Treatment of pain and inflammation with NSAIDs may be of value to some patients to improve their quality of life despite possible side effects".

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