EU regulator advises caution on painkiller diclofenac
LONDON (Reuters) - Europe's drugs agency warned on Friday that use of the common painkiller diclofenac, especially in high doses, carries extra heart attack risks which should be taken into consideration by doctors prescribing the drug.
While it said the benefits of diclofenac, which is produced by several companies, still outweighed the risks, the European Medicines Agency recommended that precautions should be taken in certain patients.
"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," it said in a statement.
EMA's decision, made by its Pharmacovigilance Risk Assessment Committee, comes after a large international study last month showed that long-term, high-dose use of painkillers such as diclofenac and ibuprofen increases the risk of a major vascular event - a heart attack, stroke or dying from cardiovascular disease - by around a third.
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 - a painkiller that U.S. drugmaker Merck pulled from sale in 2004 because of links to heart risks.
EMA also said patients with certain risk factors such as high blood pressure, raised blood 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," it added.
The agency said the safety of NSAIDs has been closely monitored in the European Union in recent years and safety reviews carried out in 2005, 2006 and 2012 found they were linked to a small increased risk of blood clots, which in some cases led to heart attacks or strokes.