In a recent drug safety communication issued by the U.S. Food and Drug Administration (FDA), the federal agency alerted patients and medical practitioners about Uloric adverse reactions which include increased heart-related death among patients. Uloric (febuxostat) is a uric acid reducer used for treatment in patients with gout.

The drug safety communication was issued after the federal agency received findings regarding increased Uloric adverse reactions, including a risk of heart-related death, in patients prescribed Uloric versus patients given allopurinol, another uric acid reducer.

In the FDA’s safety communication, they noted that “healthcare professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat.” The safety communication also advised patients to seek and discuss likely Uloric adverse reactions with their medical practitioners.

When the FDA first approved Uloric in 2009, it required the continuation of additional safety studies to be conducted. The finding that there is an increased risk of heart-related death among patients taking Uloric emerges from a safety study conducted on more than 6,000 patients taking the medication.

Prior the FDA announcement, the medication’s labeling already contained warnings and cautions of increased risk for cardiovascular events and other Uloric adverse reactions such as strokes, heart attacks, and other heart-related deaths in comparison to patients taking allopurinol.

The recent postmarketing safety study found Uloric adverse reactions involved cardiac ischemia necessitating immediate surgery, nonfatal stroke or heart attack, and cardiac-related death. The FDA is expected to receive final results of the safety study from Takeda Pharmaceuticals, Uloric’s manufacturer. Once hose results are received, the FDA plans to “conduct a full review of the data and will issue an update.”

Preliminary analysis of the study conducted by the FDA found that although there was no overall increased risk of the combinations of Uloric adverse reactions in comparison to allopurinol, there was an increased risk when patients were analyzed individually. When patients were analyzed individually, Uloric was found to increase risks for heart-related death and all-cause mortality. The FDA’s drug safety communication provided no numerical details of its findings.

Uloric and Gout

Uloric, a xanthine oxidase inhibitor, reduces the production of uric acid in the body which, in excess, can lead to kidney stones and gout. According to the Mayo Clinic, patients with gout have a high concentration of uric acid. Gout is a form of arthritis characterized by severe redness, tenderness, and pain in the joints, especially at the base of the big toe. Gout is said to occur suddenly–a person can wake up in the middle of the night feeling as if their toe is on fire.

Symptoms of gout include intense joint pain, usually affecting the large toe, but it can also occur anywhere in the body. Lingering discomfort, lasting anywhere from a few days to a few weeks are also symptoms.  Other symptoms include a limited range of motion, and redness, and inflammation. Some factors that can increase an individual’s likelihood of developing gout include diet, obesity, medical conditions, certain medications, family history of gout, and recent surgery or trauma.