Painkiller taken by millions may raise risk of heart attack, study warns

The widely prescribed painkiller diclofenac is associated with a 50 percent increased risk of heart attack or stroke, even at low doses, alarming new research shows. The study also found an increased risk of heart failure and irregular heartbeat across all ages in both men and women.

Diclofenac, previously available without a prescription, has been reclassified as a prescription-only drug in the UK due to serious concerns about side effects. Typically used for headaches, back pain, arthritis and flu-like symptoms, the drug was changed in January 2015 by the Medicines and Healthcare Products Regulatory Agency, which cited a “small but increased” risk of heart problems.

The extensive study, which included more than six million people, is believed to be the largest of its kind and links the drug to “major cardiovascular events.” Cardiologist Dr Morten Schmidt from Aarhus University Hospital in Denmark highlighted the cardiovascular risk of diclofenac compared with not using paracetamol and other traditional non-steroidal anti-inflammatory drugs.

Writing in the BMJ, Dr Schmidt advocates for access to diclofenac only by prescription, as is the case in the UK, and highlights the need for clear warnings on packaging. His team’s findings show that users of diclofenac, often sold under the brand name Voltarol, face a higher likelihood of heart-related health problems.

Patients taking diclofenac experienced a staggering 50 percent increase in the rate of health complications in just 30 days compared to those not taking any medication. There was also a 20 percent increase compared to those who used ibuprofen or paracetamol, and an alarming 30 percent jump compared to people taking naproxen. Surrey Live reports.

As Dr. Schmidt put it forcefully: “It is time to recognize the potential health risks associated with diclofenac and reduce its use.”

Diclofenac, which is commonly prescribed in the UK (five million prescriptions are written each year), belongs to the group of NSAIDs, but unlike other traditional NSAIDs, its cardiovascular risks have not been studied in large controlled trials due to ethical concerns.

Dr. Schmidt and colleagues skillfully used national registry data from more than 6.3 million middle-aged adults in Denmark for an observational study spanning two decades from 1996 to 2016. This allowed them to associate starting diclofenac with an increased risk of arrhythmia, stroke, heart failure, and heart attacks—more so than even stopping NSAIDs.

To make matters worse, taking this painkiller also signaled higher chances of cardiac death and severe internal bleeding in the upper intestines.

Dr. Schmidt emphasized: “Treatment of pain and inflammation with NSAIDs may be appropriate for some patients to improve quality of life, despite the potential side effects. However, given the risk of cardiovascular and gastrointestinal diseases, there is little reason to initiate treatment with diclofenac before other traditional NSAIDs. “

Although the absolute risk of heart attack, stroke or other cardiovascular disease remains low for individual patients, the researchers caution that no specific conclusions about cause and effect can be drawn from this observational study. However, given the large sample size, larger than many previous cohort studies, the findings provide significant weight to clinical judgment.

The MHRA warns against the use of diclofenac by people with serious heart disease. He advises people who have had heart failure, heart disease or stroke, as well as smokers and people with high blood pressure, high cholesterol or diabetes, to seek medical attention before using the medicine.

The MHRA says diclofenac will continue to be a safe and effective pain treatment, except for patients in certain risk groups. A landmark study from Oxford University in 2013 found that in every 1,000 people at moderate risk of heart disease taking 150 mg daily for a year, around three would suffer a preventable heart attack, with one resulting in to death.

European health officials then analyzed the results and recommended that people with heart disease or a history of heart attacks or strokes should no longer use diclofenac. In addition, diclofenac may provide short-term relief from toothache and menstrual cramps by inhibiting a body chemical known as cyclooxygenase, which produces substances in response to injury that lead to pain, swelling and inflammation.