The FDA has required Takeda Pharmaceuticals to update Uloric’s warning label with a black box warning about an increased risk of Uloric cardiac related death.

The agency also put a new limitation on the approved uses of Uloric. This limitation required the medication only be prescribed to patients who have been prescribed allopurinol and have not responded to it or experienced severe side effects from it.

This order is an update to two previous warnings issued on Nov. 15, 2017, in which the FDA stated it would be investigating a potential increased risk of Uloric cardiac related death.

These advisories came after Takeda had released the results of the CARES clinical trials, which reportedly found an increased risk of cardiac death and other causes of death linked to Uloric. These results were compared to those of patients who were prescribed allopurinol, a different gout drug.

Overview of Uloric Cardiac Death Risk

The CARES study was mandated by the FDA when the medication was first released, due to concerns regarding an increased risk of cardiovascular complications during early clinical trials.

This study consisted of 6,190 patients with gout, who were either prescribed Uloric or allopurinol to treat their condition. The study reportedly found that patients faced an increased risk of heart related death, along with potential other causes of death.

More specifically, the study found that Uloric patients reportedly faced an increased risk of cardiovascular death, non fatal heart attacks, non fatal stroke, and cardiac ischemia. The latter of these conditions occurs when there is a decrease in blood flow to the heart, which often requires urgent surgery.

While Uloric’s label already included a warning against potentially dangerous cardiac events, the CARES study had spurred the FDA to take more urgent action. The FDA is currently advising Uloric patients to seek emergency medical help if they experience any of the following symptoms:

• Chest Pain
• Shortness of Breath
• Rapid or Irregular Heartbeat
• Numbness or Weakness on One Side of Body
• Dizziness
• Trouble Talking
• Sudden Painful Headache

Even with the potential increased risk of cardiac death, the FDA advises patients to not stop taking Uloric without first talking to their doctor.

Uloric is a popular treatment medication for gout, which is a type of arthritis that occurs in the joints due to the buildup of uric acid. This causes sudden painful episodes of redness and swelling in the impacted joints, which is often caused by an unhealthy diet and similar lifestyle habits but other risk factors like family history can also play a part.

Uloric works by reducing the uric acid levels in the blood, which helps reduce the symptoms. This means that patients who suddenly stop taking the medication could suddenly experience painful gout flare ups or other serious complications.

Uloric patients who may have experienced complications may be eligible to join an Uloric lawsuit investigation and seek compensation for their losses.