Now a groundbreaking study of more than six million people, the biggest of its kind, has linked them to "major cardiovascular events".
When results were analyzed by baseline cardiovascular risk, the absolute number of events per 1,000 diclofenac starters per year also increased. "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".
Diclofenac is a medicine that belongs to the category of non-steroidal anti-inflammatory drugs (NSAID) and is used to treat pain and inflammation in many countries of the world (Greece is available only from pharmacies and is not prescribed).
To conduct this study, the researchers utilized the national registry data containing details on the 6.3 million adults residing in Denmark.
Writing in The BMJ, he says diclofenac should only be available with a prescription, like in the United Kingdom - and only them when also accompanied with an appropriate warning on the front of the pack. The risks were evident whether the participants took high, or low doses of the drug.
The researchers worked to assess the cardiac risk associated with diclofenac in individuals who weren't taking any NSAIDs, who had started taking other common NSAID pain relievers, and who were taking paracetamol (acetaminophen), commonly sold under the brand name Tylenol.
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The researchers said that given the risks, doctors should be initiating treatment where indicated with other types of NSAIDs before considering diclofenac.
"Treatment of pain and inflammation with NSAIDs", explain the authors, "may be worthwhile for some patients to improve quality of life despite potential side effects".
Researchers from Aarhus University Hospital in Denmark, who recently published a study British Medical Journal on the relationship between heart health and diclofenac, believe the drug should be globally banned as an over-the-counter medication.
Diclofenac was also associated with an increased rate of cardiac death and upper gastrointestinal bleeding.
Also, it's important to note that this is an observational study, so no cause-effect relationship was established.
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.
"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.