According to a Uloric FDA warning, clinical trial results show an increased chance of heart-related death with Uloric compared to allopurinol, a similar gout medication.

In November 2017, the U.S. Food and Drug Administration (FDA) released a safety alert regarding the gout medication Uloric. The Uloric FDA warning warned consumers and physicians that “preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol”.

Takeda Pharmaceuticals, the Uloric drug manufacturing company with a U.S. subsidiary in the Chicago area, was required by the FDA to conduct the safety trial after previous clinical trials showed a higher rate of heart-related events with Uloric. The problems seen in the initial clinical trials included heart attacks, strokes, and heart-related deaths.

The FDA-required safety trial studied over 6,000 gout patients treated with either Uloric or allopurinol. According to the Uloric FDA warning, “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”.

Preliminary results show that Uloric did not increase the risk of all outcomes combined when compared to allopurinol. However, when each outcome was evaluated separately, Uloric showed an increased risk of “heart-related deaths and death from all causes”.

The Uloric FDA warning includes a recommendation to healthcare professionals to “consider this safety information when deciding whether to prescribe or continue patients on febuxostat”. Professionals are also encouraged to report Uloric-related adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting System.

Patients are encouraged by the Uloric FDA warning to talk to their healthcare professionals if they have any questions or concerns about the gout medication. As with all medications, patients should not stop taking their medicine without first contacting their doctor, the Uloric FDA warning states.

Gout is a form of arthritis which involves a buildup of uric acid crystals in the joints. Uric acid typically dissolves in blood and passed through the kidneys into urine. In patients with gout, the kidneys do not properly process uric acid, causing it to build up in the joints. The buildup of uric acid can form sharp, needle-like crystals which irritate tissues. Symptoms of gout include intense joint pain, lingering discomfort, inflammation, redness, and limited range of motion.

Uloric (febuxostat) and allopurinol are medications prescribed to patients with gout. They work by preventing the buildup of uric acid in a patient’s body. According to the Uloric FDA warning, Uloric works to treat gout by lowering uric acid levels in the blood. Febuxostat was developed by Takeda in effort to offer a safer alternative to allopurinol which can cause kidney problems and severe allergic reactions.

However, Uloric may be associated with a higher risk of cardiac events. If you or a loved one experienced a cardiac event or cardiac-related death after being prescribed Uloric, you may qualify for a Uloric lawsuit. A Uloric lawsuit could help recover compensation for medical expenses, pain and suffering, wrongful death, and more.