Europe Regulators to Probe NSAID Heart Risks

The European Medicines Agency (EMA), Europe’s drug regulator, is launching a probe of NSAIDs and potential, related heart risks. NSAIDS—non-steroidal anti-inflammatory drugs—are the world’s most popular medications.

Recent studies have, again linked NSAIDs to heart health risks, said Reuters, which differs from the EMA’s conclusion five years ago that the benefit-risk balance of NSAIDs was, generally, positive, said Reuters. In other words, at the time, any risks presented by the wildly popular drugs were outweighed by their benefits.

Since, some recent, published cardiovascular safety studies have prompted the EMA to review the evidence and “clarify whether there is any need to update the opinion issued in 2006,” said the EMA, reported Reuters. NSAIDs are found in a variety of over-the-counter (OTC) medicines such as Bayer’s Aleve and Aspirin-branded medications, noted Reuters.

We just wrote that NSAIDS, such as Advil, Motrin, and Aleve, have long historical links to increased risks of adverse events. We’ve also long written about other research that has linked NSAIDs such aspirin, ibuprofen, naproxen, and prescription medications that include COX-2 inhibitors such as Celebrex (generic: celecoxib), to increased risks for heart failure, death, and even erectile dysfunction (ED). Most recently, we wrote about another study linking NSAIDs to heart risks; that study was published in the journal PLoS Medicine.

Of note, pointed out Reuters, it was increased heart risks that resulted in Merck & Co.’s selective COX-2 inhibitor, Vioxx, being withdrawn from the market. As we’ve often written, in 2004, Vioxx (rofecoxib) was withdrawn after a trial found that the drug increased risks for cardiovascular disease. Since, there has been much debate about the cardiovascular safety of both COX-2 inhibitors and traditional NSAIDs.

The recent NSAIDs study—which reviewed data from prior observational studies—suggested increased risks for serious cardiovascular issues that include the increased risk for heart attack in some patients. The study revealed that the drug, diclofenac, which poses similar risks as the now-banned Vioxx, was linked to the most heart risks—similar to those seen in Vioxx. Diclofenac is marketed under a wide array of brand names, including Voltaren and is considered the most popular NSAID in the world,.

Some other NSAIDs that have not been clinically scrutinized, appeared to also pose significant risks for cardiovascular events, pointing to the need for more research. For instance, said the team, etoricoxib, etodolac (sold under a number of names, including Apo-Etodolac), and indomethacin (sold under a number of names, including Apo-Indomethacin), are on the market in various—but not necessarily, all—countries, and might warrant additional study.

Andreas Laupacis, executive director of the Li Ka Shing Knowledge Institute of St. Michael’s Hospital in Toronto, pointed out that NSAIDs have probably been connected to heart issues for decades, but the risks are only being seen since Vioxx was pulled, reported the Globe and Mail previously. Because NSAIDs have never been studied in the same way that Vioxx was ultimately researched, some drugs’ risks may have gone unnoticed, Laupacis, said.