Uloric cardiac ischemia, a dangerous condition involving decreased blood flow, may be a side effect of the Takeda gout drug, according to new data from clinical trials.

Gout is a painful form of arthritis caused by a buildup of uric acid in the joints. Uric acid is a natural by-product of cellular processes and, in healthy individuals, is processed out of the body through the kidneys. However, individuals with gout are unable to process sufficient uric acid out of the body, resulting in painful side effects.

When uric acid builds up in the joints, it can form needle-like crystals, resulting in tissue irritation and inflammation. Symptoms of gout include intense joint pain, lingering discomfort, inflammation, redness, and limited range of motion.

Some individuals are able to manage their gout symptoms through lifestyle changes, but other are prescribed medications to manage their condition. One such medication is Uloric (febuxostat), which was developed by Takeda Pharmaceuticals, but it may come with side effect risks like Uloric cardiac ischemia.

Uloric Safety

Uloric was developed to be a safe alternative to allopurinol, a widely used gout medication which has been linked to kidney problems and severe allergic reactions.

A study mandated by the U.S. Food and Drug Administration (FDA) shows that Uloric may not actually be a safer alternative to allopurinol for some patients. The study was ordered by the FDA after initial clinical trials showed that Uloric patients were more likely to experience cardiac events, such as Uloric cardiac ischemia, in comparison to allopurinol.

The safety trial considered data from 6,000 gout patients taking either Uloric or allopurinol. In November 2017, the FDA released a safety alert warning 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.”

Cardiac ischemia is a condition in which blood flow to the heart is decreased, meaning that the heart does not receive sufficient oxygen. Long term cardiac ischemia can cause serious damage to the heart and can compromise the heart’s ability to pump blood effectively. Other potential complications associated with Uloric cardiac ischemia include abnormal heart rhythms, heart attack, or heart failure.

The most common cause of cardiac ischemia is arterial blockages, but data from the FDA’s clinical trial shows that Uloric cardiac ischemia may be a risk for gout patients independent of any arterial conditions. Although patients are encouraged to consult with their doctors and not stop their gout treatment without medical evaluation, the FDA announcement is shocking and frightening to many individuals.

If you or a loved one experienced Uloric cardiac ischemia or another cardiac event while taking the gout drug, you may qualify to take legal action against Takeda. A Uloric cardiac ischemia lawsuit could help injured patients or families of deceased patients recover compensation for medical expenses, pain and suffering, wrongful death, and more.