The gout medicine Uloric has been linked to heart-related deaths after being evaluated for cardiovascular risk compared to allopurinol—a competing drug treatment—in a long-range study.

The CARES study began in 2009 and was paid for by Takeda Pharmaceuticals Inc.—manufacturer of the gout medicine Uloric. The study was a requirement of the U.S. Food and Drug Administration (FDA) when pre-approval clinical safety studies revealed an increase in non-fatal cardiovascular problems.

While the FDA didn’t prevent the gout medicine Uloric from entering the market, the study was a condition of its commercial debut. The CARES study enrolled 6,190 gout sufferers with symptoms or history of heart conditions or events. While many enrollees dropped out of the study without word during its course, slightly over half remained active for the better part of three years.

Fifty percent of the CARES study participants were taking the gout medicine Uloric while the other fifty percent were taking the competing gout medicine allopurinol.

CARES Study Findings

Dr. William White, author of the study, indicates that this kind of prescriptive breakdown is in fact quite unusual to begin with. According to him, physicians tend to favor treatment with Allopurinol by far. Records indicate that of the eight million Americans being treated for this specific type of arthritis, only about 7.5 percent are prescribed the gout medicine Uloric.

The data generated by the CARES study concerning the gout medicine Uloric was presented in March of this year at the annual meeting of the American College of Cardiology. Its surprising conclusions were also published online in the New England Journal of Medicine. Dr. White lacked an easy explanation for the trends that the study revealed.

According to the post-market cardiovascular study, the gout medicine Uloric contributed to a 34 percent increase in heart-related death incidents if the patient in question had indications of preexisting heart disease. Secondary to having gout in the first place, sufferers generally have a higher risk of cardiovascular and kidney-related issues.

The CARES study data also indicated a 22 percent higher chance of dying from any cause while taking the gout medicine Uloric. Both of these statistics stand in comparison with allopurinol, which has been in use since 1966 consistently.

What is Gout?

Gout is a type of arthritis that generally painfully affects a small number of joints—typically one-to-two at a time—with inflammation and irritation and redness. These symptoms are secondary to a deposit of crystalized uric acid in the joint itself. The high blood uric acid build-up that makes this deposit possible is a characteristic of the disease.

The high uric acid can have a genetic component and gender bias—it is diagnosed more often in men than women. Gout is often connected in popular culture to disease of “high living,” as heavy consumption of red meats, seafood, and alcohol has been shown to be a contributing factor in its development.

Uloric, or febuxostat, is used to lower uric acid levels in people with gout. The gout medicine works by blocking the formation of uric acid in the body.

If you or a loved one was prescribed Uloric and experienced a serious cardiovascular event during treatment, you may have a legal claim.