There is a recent concern in the medical community regarding the side effects of a medication known as Uloric after a recent clinical study was published indicating an increased risk for cardiac deaths. The study reportedly found a higher likelihood of deaths caused by cardiac complications when patients were prescribed the Uloric medication.

An investigation was recently launched to better understand this concern and to determine if any patients have been adversely affected. Uloric, also known as febuxostat, is typically used to treat gout and works by lowering uric acid levels in the body.

Gout is a variant of arthritis that occurs when uric acid builds up and causes swelling and severe joint pain. While the Uloric medication is popular for this treatment purpose the results of a recent study initiated a major concern in the medical community regarding the drug’s potential side effects.

One of the reported side effects of the Uloric medication is nausea due to the treatment mechanism. However, doctors also warn that potential liver damage could occur, and patients are encouraged to report to their physician as soon as possible if they experience persistent nausea, abdominal pain, dark urine, and yellowing skin or eyes.

While the current Uloric medication warning label does mention potential cardiac events, the findings of the study may spur the FDA to require stronger warnings.

The recent study compared Uloric to gout medications Zyloprim and Aloprim, both containing the core ingredient allopurinol. The study found other potential complications could include non-fatal stroke and cardiac ischemia. The safety study analyzed over 6,000 gout patients prescribed allopurinol or the Uloric medication to evaluate the safety profiles of the medications.

The outcome of the study showed an increase of heart-related deaths, non-fatal heart attacks, non-fatal stroke, and cardiac ischemia requiring emergency surgery. Ischemia occurs when the blood supply to the heart decreases, negatively impacting the circulation system.

In addition to the recent study, initial clinical trials showed that the Uloric medication may increase the chances of cardiac events. These initial studies spurred the FDA to require Takeda Pharmaceuticals to perform an additional study after the Uloric medication was released in 2009, which resulted in the recent clinical trial.

Overview of FDA Uloric Cardiac Warning

The FDA issued two safety communications regarding the Uloric medication on Nov. 15, 2017, regarding the alleged correlation between Uloric and cardiac-related deaths. The first FDA announcement stated an investigation would be initiated into the potential likelihood of cardiac deaths caused by the gout medication, and the second one announced that the FDA would evaluate all reported deaths in conjunction with Uloric.

The announcements were released after Takeda Pharmaceuticals released the results of the new clinical trial, which indicated the Uloric medication had a higher likelihood of cardiac-related deaths when compared to allopurinol drugs.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. [P]atients 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 FDA stated.