An over-the-counter pain reliever may increase your risk of heart attack or stroke by 50 percent, according to a new study.
The large-scale study of more than 6.3 million adults found that diclofenac, sold in the United States as Volatren and Solaraze, among others, also puts patients at greater risk of gastrointestinal bleeding than those who take other analgesics.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), used to relieve fever or toothache in adults, or severe joint pain in children.
Heart worries led British regulators to ban the drug without a prescription in 2015, but the authors of the new study, published today in the British Medical Journal, are calling for global action to protect patients.
Concerns at the heart led British regulators to ban the over-the-counter medication in 2015, but the authors of the study, published today in the British Medical Journal, are calling for global action
"It is time to recognize the potential health risk of diclofenac and reduce its use," said the research team of the University Hospital of Aarhus in Denmark.
The dicofenac should not be available over the counter and, when prescribed, should be accompanied by an appropriate warning packet about its potential risks.
For the study, the team, led by Morten Schmidt, PhD, analyzed data from the national registry of more than 6.3 million Danish adults.
All of these patients had been taking prescription medications for at least a year before the study began in January 1996.
The average age of the participants who took NSAIDs ranged from 46 years to 49, and the average age of patients who started with acetaminophen, another painkiller, was 56.
To analyze the data, the researchers divided patients into groups according to their risk of heart problems: low, moderate and high.
They found that diclofenac was overwhelmingly associated with a higher rate of major heart problems and complications such as irregular heartbeat, ischemic stroke, heart failure and heart attack within 30 days of starting treatment, compared with ibuprofen, naproxen or paracetamol .
With each year they stayed in diclofenac, their risk increased, notably compared to those of other drugs, and those who do not take drugs at all.
Patients who started the study with a low risk, then took diclofenac, had an average heart attack or stroke more compared to those who took ibufrofen.
It was the same compared to those who take naproxen.
Compared to those who took acetaminophen, those who took diclofenac had three more heart attacks or strokes.
Those who did not take any drugs had the best luck: they had four heart attacks or CVA less, on average, compared to those who took diclofenac.
This increased risk affected both men and women of all ages. Even patients in low doses had an increased risk of heart attack and stroke.
Although some patients may need NSAIDs to improve their quality of life, "despite the possible side effects," diclofenac may not be the best option.
In fact, the researchers said the health concerns associated with this drug should be addressed now.