LONDON (Reuters) - Europe’s drugs regulator is launching a new review of the safety of common painkillers in the light of fresh evidence about possible risks they may pose to heart health.
Five years ago the European Medicines Agency concluded that the overall benefit-risk balance of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) remained positive.
Since then, however, a number of new cardiovascular safety studies have been published and the agency said on Friday its experts would weigh all the evidence once again “to clarify whether there is any need to update the opinion issued in 2006.”
Increased heart risks from using Merck & Co’s selective COX-2 inhibitor Vioxx led to its withdrawal from the market in 2004 — but there are also worries about the potential risks of non-selective drugs like ibuprofen, naproxen or aspirin.
NSAIDs are used in a range of over-the-counter medicines, including Bayer’s Aleve and Aspirin branded products.
They are widely taken to manage pain in patients with osteoarthritis and other painful conditions. There has been much debate about their heart safety, although various studies have failed to give clear results.
Reporting by Ben Hirschler; Editing by Hans-Juergen Peters