Uloric heart related deaths have become a major concern to the FDA and manufacturer Takeda Pharmaceuticals, with a clinical study finding an increased incidence rate.

The FDA recently released two warnings regarding these drug complications, with the agency stating the clinical study found an increased risk of Uloric heart related deaths and were looking into all other potential fatalities allegedly related to the drug.

The post market study found that gout patients faced an increased Uloric heart related deaths compared to those prescribed allopurinol. Takeda Pharmaceuticals had funded the clinical study, which showed an increased risk of Uloric heart related deaths or having potentially cardiac complications.

The clinical trial consisted of over 6,000 gout patients who were either prescribed Uloric or allopurinol, with researchers recording the side effects the subjects experienced.

According to the study, patients faced an increased risk of Uloric heart related deaths, non-fatal heart attacks, non fatal stroke, and cardiac ischemia. Cardiac ischemia is a condition that occurs when the blood supply to the heart becomes insufficient, and often requires urgent surgery.

The results of this clinical study had spurred the FDA into making those announcements on Nov. 15, 2017, with the agency stating that it would also be analyzing all potential deaths related to Uloric. However, the current concern of Uloric heart related deaths is the primary focus of this investigation.

Overview of Concern of Uloric Related Heart Deaths

Uloric was approved by the FDA in 2009 to be a gout treatment medication and is prescribed to millions of patients suffering from toe joint pain. Gout is a type of inflammatory arthritis in the toes or other joints, and is caused by too much uric acid in the body.

Uloric works by inhibiting xanthine oxidase in the body, which reduces the amount of uric acid and ultimately treats the severe pain and swelling caused by the condition. While this gout medication has treated numerous patients, health officials were concerned over serious Uloric drug side effects before its release.

When the gout medication first entered the market, the FDA asked Takeda Pharmaceuticals to conduct a clinical study to investigate Uloric heart related deaths and other cardiac-related complications that may be linked to Uloric. The FDA ordered this after finding that preliminary reports indicated an increased risk of Uloric heart related deaths.

“The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes,” the FDA stated.

After the results of the clinical study were submitted to the FDA, the agency recommended that patients and healthcare professionals should “consider this safety information when deciding whether to prescribe or continue patients on febuxostat.

Patients should talk to your health care professionals if you have any questions or concerns.” Takeda Pharmaceuticals is the largest pharmaceutical company in Japan and is one of the top 15 drug manufacturers in the world and is responsible for providing disclosures to their customers.

Patients who suffered Uloric cardiac complications may be able to file legal action against Takeda, and potentially receive compensation for medical bills or other related damages.