A class action investigation has been launched against Takeda Pharmaceuticals after a clinical study found an increased risk of Uloric cardiac ischemia. The FDA also issued a public warning regarding Uloric cardiac ischemia, stating that the clinical study revealed an increased risk of deaths linked to cardiac complications.

The CARES study not only observed alleged cases of Uloric cardiac ischemia but had also observed all other potential patient deaths related to the gout medication. The study had compared Uloric to allopurinol and compared the different side effects patients experienced.

The clinical study consisted of over 6,000 patients who either prescribed Uloric or allopurinol for gout treatment, with patients experiencing a number of cardiac problems.

The CARES study was published on March 12, 2018, in the New England Journal of Medicine Scientists had observed these gout patients for two and half years. The FDA announced the results of the CARES study in November 2017, when it released a public warning regarding Uloric cardiac ischemia.

According to the results of the trial, the drug complications patients experienced included: cardiac-related death, nonfatal heart attacks, nonfatal strokes, and cardiac ischemia that required urgent treatment surgery. Cardiac ischemia is a medical condition that occurs when the heart becomes unable to sufficiently pump blood into the heart.

While Uloric reportedly indicated a slightly higher risk of cardiac complications, researchers stated the results were not statistically significant in regards to Uloric cardiac ischemia. However, researchers did note that there was an increased of death in general.

Soon after reviewing the results of the study, the FDA issued two drug safety warnings on Nov. 15, 2017, regarding Uloric cardiac ischemia. One of the warnings stated that Uloric patients may face an increased risk of cardiac death, with the second one stating that the FDA would be evaluating all potential deaths associated with Uloric use.

Overview of Uloric Cardiac Ischemia Risk

The FDA approved Uloric in 2009 to treat gout in adult patients, which works by decreasing the level of uric acid in the blood. Gout is a type of arthritis that occurs when uric acid builds up in one or more joints, which causes redness and swelling.

Uloric is routinely prescribed to treat this common condition, which makes its alleged correlation to cardiac ischemia and other cardiovascular problems very troubling.

Upon Uloric’s approval, the FDA required Takeda Pharmaceuticals to perform additional studies on the drug’s potential side effects after initial clinical trials indicating an increased of heart attack, stroke, and cardiovascular death.

While these problems were included on the drug’s warning label, the post clinical trial further indicated a risk.

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

Even though Uloric cardiac ischemia can be potentially fatal to patients, Takeda Pharmaceuticals may have failed to adequately warn patients. Uloric patients who may have suffered cardiac complications may be able to file legal action to seek medical compensation.