The gout drug Uloric is reportedly associated with an increased risk of heart-related deaths, according to an FDA alert following clinical trial results.

Gout is a form of arthritis which arises due to an increased level of uric acid in the body. Uric acid is a normal byproduct of cellular processes, but individuals with gout have elevated levels of uric acid in their body which causes the formation of needle-like crystals in the joints (most often the fingers).

Some patients find that they are able to treat their gout through lifestyle changes and inflammation management. Other patients use gout medications such as Uloric or allopurinol to manage the levels of uric acid in their bodies. However, the U.S. Food and Drug Administration (FDA) released a warning last year suggesting that Uloric may not be the best choice for gout treatment due to newly discovered risk.

In March 2018, the results of an FDA mandated clinical trial were published in the New England Journal of Medicine. The trial was mandated by the FDA after initial clinical trials showed an elevated risk of adverse cardiovascular events in patients taking Uloric.

Although general cardiovascular events were on par with allopurinol, the CARES trial showed that the drug Uloric was associated with an increased risk of death from cardiovascular and other causes. The primary outcome was reportedly cardiovascular death, non-fatal stroke, non-fatal heart attack, and cardiac ischemia (a condition involving decreased blood supply to the heart) requiring urgent surgery. 

The CARES trial examined outcomes of 6,190 patients who were treating their gout with either allopurinol or the drug Uloric. Uloric was reportedly associated with a 34 percent increased risk of death from cardiovascular causes and a 22 percent increased risk of death from any cause. In patients with a history of chronic kidney disease, mortality deaths were reportedly similar among allopurinol and Uloric patients.

45 percent of patients reportedly stopped taking Uloric before the CARES study ended. The increased risk of death was reportedly diminished after they stopped taking the drug, but overall more patients died after stopping their assigned drug than while taking it.

The study reportedly also showed an increased risk of death in patients who did not take aspirin and in patients who regularly took nonsteroidal anti-inflammatory drugs (NSAIDs). Although these results may be significant, researchers from the study noted that the CARES trial was not designed to study drug interactions and that the reason remains undetermined, requiring further analysis.

“It is important to be careful when interpreting these findings; it doesn’t necessarily indicate there’s an interaction between these drugs and febuxostat,” said Dr. William B. White, lead researcher for the CARES study, according to the American College of Cardiology. “It might have been that these patients had more active gout with more flares, for example.”

The researchers reportedly plan to examine their data further for additional insights into the best treatment option for gout patients with cardiovascular disease and kidney disease. Similar studies are reportedly ongoing in Europe to examine the safety profile of Uloric for patients at risk for cardiovascular events without already having been diagnosed cardiovascular disease.