Uloric May Carry Risk of Fatal Heart Problems: Study

The findings of a new study raise further concerns about the potential heart risks with Uloric, a widely used gout medication. 

Researchers with the University of Connecticut School of Medicine and Takeda Pharmaceuticals indicate that individuals taking Uloric face a higher risk of death due to heart problems than those taking Zyloprim (allopurinol), in a report published this week in the New England Journal of Medicine.

Uloric (febuxostat) is a Takeda Pharmaceuticals medication approved for the treatment of gout by the FDA in 2009. It already carries a warning of an increased risk of heart attacks, strokes and cardiovascular death, which were seen in its initial clinical trials.

Those findings led the FDA to require additional post-marketing safety research, and the results of that research raised further concerns among health experts, and the FDA issued a drug safety warning on Uloric heart risks in November 2017..

In this latest study, researchers conducted a multicenter, double-blind trial on more than 6,000 patients with gout and cardiovascular disease to see if Uloric and Zyloprim had comparable safety. The researchers noted that cardiovascular risks are already increased in patients with gout.

According to the findings, the overall cardiovascular risk of the two drugs was comparable. However, the risk of death overall was 22% higher with Uloric than Zyloprim, and the risk of cardiovascular death was 34% higher.

“In patients with gout and major cardiovascular coexisting conditions, febuxostat was noninferior to allopurinol with respect to rates of adverse cardiovascular events,” the researchers concluded. “All-cause mortality and cardiovascular mortality were higher with febuxostat than with allopurinol.”

Concerns about the potential side effects of Uloric were raised in a whistleblower lawsuit filed in 2012 by Helen Ge, a former safety consultant with Takeda Pharmaceuticals. In her lawsuit, Ge alleged that Takeda defrauded Medicare and Medicaid by failing to report that Uloric could cause dangerous side effects when used in combination with other drugs, such as digoxin, imuran, methadone, and warfarin. Some of those interactions have been fatal, she warned.

The interactions Ge reported included bone marrow failure, severe bleeding and kidney failure. She claimed that Takeda altered and falsified adverse event reports sent to the FDA to make Uloric side effects appear less severe.

Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.