Popular painkillers increase risk of heart attack and stroke

A large study of more than 6.3 million adults found that diclofenac, also known by the brand names Volatren and Solaraze, among others, also put patients at higher risk of gastrointestinal bleeding than other painkillers.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), commonly used to reduce fever or relieve toothache in adults, or severe joint pain in children.

Heart concerns prompted UK regulators to ban the over-the-counter drug in 2015, but the authors of the new study, published in the British Medical Journal, call for global action to protect patients.

“It is time to acknowledge the potential health risks of diclofenac and reduce its use,” said the team from Aarhus University Hospital in Denmark.

“Dicofenac should not be sold without a prescription, and when prescribed it should be accompanied by appropriate warnings on the packaging about its potential risks.”

The research team analyzed national registry data for more than 6.3 million Danish adults.

All of these patients had been taking prescription medications for at least one year before the study began in January 1996.

The average age of those taking NSAIDs ranged from 46 to 49 years, and the average age of patients starting paracetamol, another painkiller, was 56.

To analyze the data, researchers divided patients into groups depending 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 increased significantly with each year of diclofenac use compared with other drug users, and non-users.

Patients who were at low risk at the start of the study and then took diclofenac had, on average, one more heart attack or stroke than those taking ibuprofen. The results were similar for those taking naproxen.

Compared with those taking paracetamol, those taking diclofenac had three more heart attacks or strokes.

Those who did not take the drug fared best: they had, on average, four fewer heart attacks or strokes than those taking diclofenac.

The increased risk occurred in both men and women of all ages. Even patients taking low doses had an increased risk of heart attack and stroke.

Although some patients may need an NSAID to improve quality of life, “despite the potential side effects,” diclofenac is probably not the best choice.

Researchers say health concerns related to the drug must be addressed now.