The FDA recently issued a public safety warning regarding the side effects of Uloric for gout, including high risk of cardiac death.

The FDA discovered these side effects of Uloric for gout after reviewing a study that compared the medication to other treatment medication allopurinal (Zyloprim and Aloprim).

The FDA issued two warnings regarding the side effects of Uloric for gout released on Nov. 15, 2017, with the first warning about potential death from cardiac complications and the second one stating the FDA would be evaluating all causes of death including cardiac deaths related to Uloric.

The FDA released these warnings after the drug’s manufacturer, Chicago area-based Takeda Pharmaceuticals, released results of a clinical trial showing an increased risk for cardiac related events and deaths from Uloric compared to another gout treatment drug, allopurinol.

Uloric (febuxostat) was approved by the FDA in 2009 to be a treatment medication for gout. This medication works by lowering the levels of uric acid in the blood which can develop into gout if allowed to accumulate. Gout is a painful type of arthritis that can result in redness, swelling, and serious pain in joints.

Even though this drug is very popular, there was concern building up around the side effects of Uloric for gout even before the drug was released. This was because initial clinical trials had shown significant risks of cardiac deaths, spurring this safety study.

Overview of Uloric Safety Study

The study analyzed over 6,000 patients prescribed Uloric or allopurinol, with the purpose of the study to evaluate the risk for cardiac events. The FDA mandated this study after pre-clinical trials showed that Uloric could increase the chances of cardiac events.

The outcome of the study showed that the side effects of Uloric for gout could outweigh the drug’s benefits, with the study finding an increased risk for cardiac related death, non-fatal heart attack, non-fatal stroke and cardiac ischemia requiring emergency surgery.

While initial analysis of the study indicated that Uloric did not carry an overall increased risk of potentially fatal cardiac attacks, scientists noticed the risk was much greater when each subject was examined separately. With a stand-alone analysis of each subject, scientists found that Uloric carried a high risk of cardiac related deaths and other fatality causes.

While the specific results of the study were not mentioned in the FDA’s warning, the agency did state that it plans to conduct a full review of the inquiry when Takeda Pharmaceuticals sends the final results of the study. The FDA stated that will provide an update when available.

In the meantime, the agency stated that healthcare professionals should consider these potential side effects of Uloric for gout when considering prescribing treatment medication. Patients who have concerns regarding the drug’s alleged cardiac complications should discuss them with their physicians.

At this time, a class action investigation has been launched into Takeda Pharmaceuticals after the FDA issued these warnings. The investigation is centered around injury reports regarding cardiac attacks or cardiac death and trying to determine if Takeda acted negligently.