Common pain relievers increase the risk of heart attack and stroke.
An over-the-counter painkiller may increase the risk of heart attack or stroke by 50%, a new study has found.
A large-scale study involving more than 6.3 million adults found that diclofenac, also known by the brand names Volatren and Solaraze among others, also puts patients at a higher risk of gastrointestinal bleeding compared to other pain relievers.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), commonly used to reduce fever or relieve toothache in adults, or severe joint pain in children.
Concerns about heart problems led UK regulators to ban the over-the-counter drug in 2015, but the authors of the new study, published in the British Medical Journal, are calling for global action to protect patients.
"It's time to acknowledge the potential health risks of diclofenac and reduce its use," said a research team from Aarhus University Hospital in Denmark.
"Dicofenac should not be sold without a prescription, and when a prescription is required, appropriate warnings about its potential risks should be included on the packaging."
The research team analyzed national registration data for more than 6.3 million Danish adults.
All of these patients had been taking prescription medication for at least one year before the study began in January 1996.
The average age of people taking NSAIDs ranges from 46 to 49 years, and the average age of patients starting paracetamol, another pain reliever, is 56.
To analyze the data, researchers divided patients into groups based on their risk of heart attack—low, medium, and high.
They found that diclofenac was strongly associated with an increased rate of serious cardiovascular 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.
The risk increases significantly with each year of diclofenac use compared to those using other medications, and those not using the medication at all.
Patients at low risk at the start of the study, who subsequently received diclofenac, experienced an average of one more heart attack or stroke compared to those receiving ibuprofen. Similar results were observed in those receiving naproxen.
Compared to those using paracetamol, those using diclofenac had three more heart attacks or strokes.
Those who didn't take the medication fared best: on average, they had four fewer heart attacks or strokes than those who took diclofenac.
The increased risk occurs in both men and women of all ages. Even patients taking low doses have an increased risk of heart attack and stroke.
Although some patients may need NSAIDs to improve their quality of life, “regardless of the potential side effects,” diclofenac is probably not the best option.
Researchers argue that health concerns related to the drug must be addressed now.