The Food and Drug Administration (FDA) issued a warning that the gout drug Uloric (febuxostat) was linked to an increase in heart-related deaths in a recent study. The study compared Uloric to allopurinol, sold under the name brands Zyloprim and Aloprim.

The study found that when taking Uloric, the risk of heart-related deaths increased as well as deaths from all causes. Other serious side effects from Uloric tablets include non-deadly heart attacks, non-deadly strokes, and cardiac ischemia requiring urgent surgery.

Overview: Uloric & Heart-Related Deaths

The FDA issued two Drug Safety Communications on Nov. 15. One said that the federal agency would be evaluating the increased risk of heart-related deaths linked to Uloric and the second one said that it would be evaluating death from all causes as well as heart-related deaths linked to Uloric.

The announcement came after Uloric’s drug maker, Takeda Pharmaceuticals, released the results of a clinical trial that showed an increase in the risk of fatal heart-related events and death from all causes when compared to the gout drug allopurinol.

The clinical trial included more than 6,000 gout patients who were taking either Uloric or allopurinol. The primary outcome of the trial showed a combination of side effects: heart-related death, non-deadly heart attack, non-deadly stroke and cardiac ischemia requiring urgent surgery. Ischemia occurs when there is a decrease in the blood supply to the heart.

Uloric was approved by the FDA in 2009. The initial clinical trials performed showed an increased risk of heart attacks, strokes and heart-related deaths, which are included on the warning label of the drug. It was because of these findings that the federal agency required Takeda to perform an additional study after the drug was released.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat,” the FDA stated. “Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”

Gout is a type of arthritis that occurs when there is a build-up of uric acid, leading to redness, swelling, and severe pain in one or more joint. Gout drugs like Uloric and allopurinol lower the uric acid levels in the blood.

Takeda Uloric Side Effects Whistleblower Lawsuit

The serious Uloric side effects were the subject of a whistleblower lawsuit in 2012 filed by a former Takeda safety consultant who claimed that the drugmaker hid important information about negative side effects from the federal government.

The whistleblower lawsuit specifically alleged that Takeda failed to reveal that Uloric could lead to potentially fatal side effects when combined with other drugs such as digoxin, imuran, methadone, and warfarin. The failure to reveal this information reportedly led to the death of some Uloric patients.

In addition, the lawsuit claimed that Takeda failed to report that Uloric could also cause bone marrow failure, severe bleeding, and kidney failure. The former Takeda safety consultant also said that the drug maker made Uloric side effects seem not as severe by changing and falsifying documents that were sent to the FDA.

The plaintiff claimed these alleged actions by Takeda defrauded Medicare and Medicaid because gout patients were diverted from taking allopurinol, which costs 10 cents per day, to taking Uloric, which costs $5 per day.