The Takeda Uloric drug has been associated with a higher risk of heart-related death. Those patients currently taking the gout medication should consult with their physician immediately about whether or not the risks outweigh the benefits of this drug. However, patients should not stop taking their medications without medical supervision.

Patients given Uloric should continue to monitor their heart condition to ensure they have not developed issues. Side effects of the Takeda Uloric drug can manifest suddenly and sometimes these are even fatal if the patient is not able to get medical attention immediately.

Fatal heart side effects have been reported in clinical studies undertaken to better comprehend the full risk of Uloric medicine.

Uloric Risks

The Takeda Uloric drug is a medication given to those patients who have been diagnosed with gout. However, recent research has indicated that the Takeda Uloric medication carries a unique set of risks for heart-related death. That research project evaluated the Takeda Uloric brand to another medication known as Allopurinol.

Allopurinol is sold under name brands; Alloprim and Zyloprim. The study identified that when taking Uloric, the patient experienced a much higher risk of heart-related death as well as death from other causes.

Other severe side effects were reported by those who were taking the gout medication, including cardiac ischemia, non-deadly strokes, and non-deadly heart attacks. A diagnosis of cardiac ischemia could require immediate surgery for an affected patient.

The Food and Drug Administration (FDA) is currently evaluating the heart-related death risks associated with the Takeda Uloric drug. A clinical trial released by Takeda Pharmaceuticals indicated that, in comparison with Allopurinol, those patients taking Uloric were at risk of severe side effects and symptoms, some of which could be deadly if not caught quickly and reported to a doctor.

The clinical trial that led to those research results included more than 6,000 patients who were taking Allopurinol or the Takeda Uloric version. Initially approved by the Food and Drug Administration in 2009, Uloric’s first clinical trials indicated that there was a higher risk of strokes, heart-related deaths, and heart attacks. These Uloric side effects were indicated on the warning label of the drug.

These initial findings are what prompted the Food and Drug Administration to require the pharmaceutical company Takeda to carry out further research regarding these problems. This additional clinical research trial is what indicated that patients may still be at risk of significant side effects and heart-related deaths, many of which could have been avoided by taking an alternative.

Uloric Label Changes

In January 2019, an FDA panel voted on whether or not to add new warnings to Uloric’s warning in order to inform patients of the risk of heart-related death.

The panel, which was a joint effort between the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, voted 19 to 2 with one abstention to determine that the risk of heart-related risk outweighs the benefits of Uloric treatment in some patients.

After the decision, the FDA decided to add their “most prominent” boxed warning to Uloric’s labeling and required a new patient medication guide. The agency also decided to limit the approved use of Uloric to only patients who are not treated effectively with allopurinol or who experience “severe side effects” with the other gout drug.

Despite the FDA’s recent decision, Takeda reportedly remains confident in the safety and efficacy of their gout medication.

“Patient safety has always been our first priority at Takeda, and we appreciate that common purpose and the thoughtful discussion […] with the Advisory Committee members about CARES,” said Tom Harris, senior vice president and head of global regulatory affairs for Takeda, in a press release following the FDA committee’s decision.

“We have studied the safety of Uloric for more than 15 years, and remain confident in Uloric as an important option for the chronic management of hyperuricemia in gout. We look forward to additional discussions with the FDA regarding these CARES data.”

Uloric Whistleblower Lawsuit

A whistleblower lawsuit in 2012 also pointed out the possible issues associated with the Takeda Uloric formulation. One former Takeda safety consultant was at the center of that whistleblower claim, arguing that the drug manufacturer went out of their way to conceal the dangerous side effects from the federal government.

The whistleblower alleged that Takeda failed to reveal that some of the side effects linked to Uloric could be fatal, a subject that has been consistent in the growing consumer complaints over Uloric use.