European Drug Regulator Urges Caution in Use of Painkiller Diclofenac

The European Medicines Agency (EMA), Europe’s drug regulator, warned on Friday that the painkiller diclofenac, especially in high doses, carries extra heart attack risks, which should be taken into consideration by doctors prescribing the drug.

“Patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke, should not use diclofenac,” the EMA said in a statement. The EMA’s warning comes after a large international study showed that long-term, high-dose use of non-steroidal anti-inflammatory (NSAID) painkillers such as diclofenac and ibuprofen increases the risk of a major vascular event—heart attack, stroke, or death from cardiovascular disease—by around a third, Reuters reports.

This puts the heart risks of generic non-steroidal anti-inflammatory drugs (NSAIDs) like diclofenac on a par with a newer class of NSAIDs known as COX-2 inhibitors or coxibs, which includes Vioxx, the painkiller drugmaker Merck pulled from sale in 2004 because of links to heart risks, according to Reuters.

The EMA statement warned that patients with risk factors such as high blood pressure, elevated cholesterol, diabetes, or smoking should “only use diclofenac after careful consideration.” “Healthcare professionals will also be advised to periodically re-assess the need for patients to continue taking the medicine,” according to the EMA statement. While NSAIDs are effective in reducing joint pain and swelling, allowing many arthritis patients to enjoy a better quality of life, the safety of NSAIDs has been closely monitored in recent years. Safety reviews have linked NSAID use to an increase in risk for blood clots, which can lead to heart attacks or strokes, Reuters reports.