'Little justification' for prescribing diclofenac, researchers warn

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

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

Side effects included an irregular heartbeat or flutter, heart failure, ischemic stroke and heart attack.

'It is time to acknowledge the potential health risk of diclofenac and to reduce its use.

Researchers concluded: "Diclofenac poses a cardiovascular health risk compared with non-use, paracetamol use, and use of other traditional non-steroidal anti-inflammatory drugs". The researchers' paper is titled, "Diclofenac use and cardiovascular risks: series of nationwide cohort studies".

The potential link between non-aspirin NSAIDs and cardiovascular has been a major concern since the thromboembolic risks associated with rofecoxib were reported back in 2005, the researchers write. Some researchers suggest the risk means the drug should only be available as a prescription.

These population-based registries allowed the team to emulate the level and depth of data that would be collected through a controlled clinical trial.

Dr Morten Schmidt, of Aarhus University Hospital in Denmark, is now urging for the drug to come with a warning - and that other countries should copy the United Kingdom and make it prescription only.

A study carried out by researchers in Denmark looked at nearly 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 British Heart Foundation (BHF) have previously said that patients should be on the lowest dose possible of NSAIDs for the shortest possible time. The average age was 46-49 years among NSAID initiators, and 56 years among those who started taking paracetamol.

The researchersadvised 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. The risks were evident whether the participants took high, or low doses of the drug.

Beginning the use of diclofenac was also associated with an increased rate of cardiac death in comparison with no NSAIDS, and an increased risk of upper gastrointestinal bleeding compared with not using NSAIDS, beginning to use ibuprofen or paracetamol.

However, he added that non-steroidal anti-inflammatories (NSAIDs) is still "worthwhile for some patients" - although he said patients should try other NSAIDs first before diclofenac.

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