The FDA issued a warning last fall that Uloric cardiac related death was a greater risk for patients taking Uloric than for others who took a competing gout medication, allopurinol.

Preliminary reports of a safety study by Uloric (febuxostat) manufacturer Takeda Pharmaceuticals indicated an increased risk of heart attacks, strokes, and heart-related death. The safety trail looked at more than 6,000 gout patients who were treated with either Uloric or allopurinol. The study showed that Uloric cardiac related death was a greater risk, and deaths from all causes were higher in the Uloric group.

Uloric also was linked to non-deadly heart attack, non-deadly stroke, and a lack of adequate blood supply to the heart that required emergency surgery.

“The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol,” said the FDA warning. “However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”

The FDA said it is continuing to evaluate the study’s results.

Is Uloric Cardiac Related Death Reason for a Recall?

Public Citizen, a non-profit consumer advocacy organization, petitioned the FDA to ban Uloric due to the increased risk of Uloric cardiac related death. The organization argues that if the study would have been done prior to Uloric’s 2009 FDA approval, the drug most likely would not have made it to the market. In a letter sent to the FDA on June 21, 2018, Public Citizen urged the FDA to take Ulori off the market.

The petition says there is “overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit.”

Takeda made $1.9 billion in sales of Uloric from 2012 through 2017 in the U.S. alone. Most of these patients who began taking the medication prior to the FDA’s warning had no way of knowing of the potential dangers revealed by the subsequent study.

Whistleblower Lawsuit Brought Attention to Problems

In 2012, a former Takeda employee filed a whistleblower lawsuit. She said she was a safety consultant who alleged she saw Takeda hiding important safety information about Uloric and other drugs, including potentially dangerous side effects.

The former safety consultant said that Takeda allegedly failed to indicate that it knew Uloric could cause fatal side effects when mixed with certain other medications, including digoxin, imuran, methadone and warfarin. By not knowing these critical contraindications, an unknown number of Uloric patients purportedly died.

The whistleblower lawsuit also alleged Takeda neglected to report Uloric was linked to causing bone marrow failure, severe bleeding and kidney failure.

Takeda allegedly changed and falsified clinical reports and documents prior to sending them to the FDA. The edited versions of the documents allegedly watered down the severity of the side effects, including the potential of Uloric cardiac related death.

Takeda’s alleged fraudulent actions affected Medicare and Medicaid programs, as well, said the whistleblower lawsuit. Instead of taking allopurinol for ten cents per day, patients were prescribed Uloric, which cost $5 per day in most markets, argued the lawsuit.