According to an FDA safety alert last year, patients taking Uloric, a Takeda gout drug, may be at risk for cardiac events including cardiac ischemia, heart attack, stroke and cardiac death.

Following a safety alert released by the U.S. Food and Drug Administration (FDA) in November 2017, Uloric patients have been warned that a safety trial showed the Takeda gout drug may increase the chance of cardiac side effects.

Gout is an arthritic condition in which uric acid builds up in a patient’s joints. Uric acid is naturally produced by cells and processed out of the body via the kidneys. In gout patients, the kidneys to not effectively filter out uric acid.

This can lead to a build-up of uric acid in the joints where it can form sharp, needle-like crystals resulting in tissue irritation and inflammation. Commonly reported gout symptoms include intense joint pain, lingering discomfort, inflammation, redness and limited range of motion.

To combat the debilitating effects of gout, some patients are prescribed Uloric. Uloric (febuxostat) was developed by Takeda Pharmaceuticals to reduce the levels of uric acid in the blood and thereby reduce gout symptoms. The Takeda gout drug was developed as an alternative to allopurinol, a popular gout medication which carries the risk of kidney problems and allergic reactions.

Although Uloric was intended to be a safer alternative to allopurinol, the Takeda gout drug reportedly carries a higher risk of cardiac events. According to data released from an FDA mandated safety trial, Uloric is associated with a higher risk for cardiac ischemia, stroke, heart attack and death.

The FDA required the safety trial after an earlier clinical trial suggested that Uloric patients were at a higher risk for cardiac events than allopurinol patients. The safety trial analyzed data from 6,000 gout patients treated with either Uloric and allopurinol. According to a safety alert released by the FDA, the initial results of the trial were not promising.

In a November 2017 safety alert, the FDA revealed that the primary outcome of the mandated safety trial 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”.

The safety alert sought to inform patients and physicians of the newfound risks associated with the Takeda drug. Health care professionals are encouraged to consider the new data when prescribing or continuing to prescribe Uloric to patients.

Consumers are encouraged to speak with their doctors regarding any concerns and to not stop taking the Takeda gout drug without consulting with their health care team.

Amid the new information that the Takeda gout drug may cause cardiac side effects, some consumers are turning towards legal measures to seek compensation. These consumers claim that they were not sufficiently warned of the high cardiac risks associated with Uloric and aim to hold Takeda accountable.

If you or a loved one experienced cardiac ischemia, heart attack, stroke or cardiac-related death after taking Uloric, you may be able to seek relief via litigation. A Uloric lawsuit could recover compensation for medical expenses, pain and suffering, wrongful death and more.