Uloric heart-related death may be a side effect of the gout drug according to the results of an FDA mandated clinical trial.

When individuals think of arthritis, they often imagine pain in major joints and ligaments. However, gout is a form of arthritis which often targets the fingers and toes. Gout occurs due to a buildup of uric acid in the joints which can form needle-like crystals.

Although uric acid is a natural by-product of cellular processes, individuals with gout are unable to sufficiently process uric acid out of the blood which can cause problems. Common symptoms of gout, caused by inflammation and irritation from uric acid crystals, include intense joint pain, lingering discomfort, inflammation, redness and limited range of motion.

Some individuals’ gout symptoms are able to be managed through lifestyle changes. However, other individuals are prescribed medications to manage their condition and pain levels. One medication used to treat gout is Uloric, manufactured by Takeda Pharmaceuticals.

The drug was developed by Takeda to be a safer alternative to allopurinol, a gout medication which has been associated with kidney problems and allergic reactions.

However, Uloric heart-related death may be a problem associated with the gout medication. A study mandated by the U.S. Food and Drug Administration (FDA) showed that Uloric heart-related death was more common with the drug than with allopurinol.

The study was required by the FDA after initial clinical trials showed an alarming number Uloric heart-related death and cardiac events.

The FDA mandated trial analyzed data from 6,000 gout patients taking either Uloric or allopurinol to manage their condition.

In November 2017, after the FDA reviewed the results of the Uloric heart-related death study, the agency warned that “the primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.”

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat,” the FDA stated. “Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”

The possibility of Uloric heart-related death was allegedly unwarned by Takeda when advertising the gout medication. Patients or families of patients who experienced Uloric heart-related death have filed lawsuits against Takeda for failing to warn consumers despite allegedly being aware of the risks.

The alleged concealment of Uloric heart-related death was the subject of a 2012 whistleblower lawsuit filed by a former Takeda safety consultant. The former employee claimed that Takeda hid vital information about Uloric heart-related death and other side effects of the gout medication.

According to the lawsuit, Uloric can cause serious side effects when combined with drugs such as digoxin, imuran, methadone and warfarin. The drug can allegedly also cause bone marrow failure, severe bleeding and kidney failure.

The whistleblower lawsuit alleged that Takeda falsified documents sent to the FDA in order to downplay the severity of Uloric side effects and Uloric heart-related death.