New data suggests that Uloric, a gout medication, may result in cardiac ischemia or other cardiac events including heart attack, stroke, and cardiac death.

Gout is a form of arthritis involving a buildup of uric acid in the joints. Uric acid is a by-product of cellular processes and is typically processed through the kidneys.

In individuals with gout, the kidneys do not sufficiently process uric acid and it builds up in the joints where it can form needle-like crystals. This results in tissue irritation, inflammation, and pain. Common symptoms of gout include intense joint pain, lingering discomfort, inflammation, redness, and limited range of motion.

Uloric (febuxostat) is a gout medication which lowers the levels of uric acid in the blood. The drug was developed by Takeda Pharmaceuticals, a drug manufacturing company with a U.S. subsidiary in the Chicago area. Uloric was developed as an alternative to allopurinol, a popular gout medication which can cause kidney problems and allergic reactions.

However, new data from an FDA mandated safety trial shows that Uloric may be associated with a higher risk of cardiac events such as cardiac ischemia, stroke, heart attack, and death. The safety trial was required by the federal agency after an earlier clinical trial showed a higher risk of cardiac events in Uloric patients when compared with allopurinol patients. The safety trial studied 6,000 gout patients who were taking either Uloric or allopurinol and compared outcomes in these patients.

In November 2017, the FDA released a safety alert with results from the trial, stating that “the primary outcome 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 final cardiac condition referenced in the alert is commonly known as cardiac ischemia.

Cardiac ischemia involves a decreased blood flow to the heart which prevents it from receiving enough oxygen. Prolonged cardiac ischemia can result in damage to the heart, limiting its ability to pump blood effectively. The condition may also result in abnormal heart rhythms, heart attack, or heart failure.

Cardiac ischemia is often caused by partial or complete blockages of the heart’s coronary arteries. However, data from the Uloric FDA trial suggests that the drug may also cause the condition. Symptoms of cardiac ischemia sometimes do not appear, so Uloric patients who develop the condition may not know they have it until it is too late. However, when cardiac ischemia symptoms do appear they often include neck pain, jaw pain, shoulder pain, arm pain, fast heartbeat, shortness of breath, nausea, vomiting, sweating, and fatigue.

Following the FDA safety trial and subsequent safety alert, patients taking Uloric are encouraged to speak with their doctors about any questions or concerns. Health care professionals are encouraged to consider the new safety information when prescribing or continuing to prescribe Uloric to gout patients.

If you or a loved one developed cardiac ischemia or another cardiac condition after taking Uloric, you may be eligible for legal action against Takeda. A Uloric cardiac ischemia lawsuit could help recover compensation for medical expenses, pain and suffering, wrongful death, and more.