The gout drug Uloric has been recently linked with an increased risk of cardiac related deaths compared to similar treatment drugs. Uloric had been linked with an increased rate of cardiac related deaths after the FDA reviewed a recent study which compared the medication to allopurinol.

More specifically, the FDA reviewed the preliminary results from a safety clinical trial observing the side effects of the gout drug Uloric. In March 2018, a full review of the study was released and was published in the New England Journal of Medicine.

The study reportedly found that patients prescribed the gout drug Uloric and had pre-existing cardiovascular conditions faced a greater risk of potentially fatal cardiac episodes, with scientists also finding that all other causes of death and cardiovascular deaths were higher in Uloric patients than allopurinol.

The FDA issued two public warnings on Nov. 15, 2017 regarding the gout drug Uloric, with one stating the federal agency would be evaluating the increased risk of cardiac related deaths linked to the medication. The second warning stated the FDA would be evaluating all deaths potentially linked to the gout drug Uloric.

Biospace reports that the results of the study spurred consumer advocacy group Public Citizen to petition of the FDA to pull the gout drug Uloric off the market, stating there is “overwhelming evidence that the serious cardiovascular harms of [Uloric] outweigh any purported clinical benefit.”

Public Citizen also alleges Takeda Pharmaceuticals failed to provide sufficient information regarding their gout treatment drug’s potential side effects, or how effective it is in actually preventing gout.

“The agency should have demanded that an appropriately designed clinical trial to assess febuxostat’s cardiovascular risks be conducted before, not after approval,” said Michael Carome, director of Public Citizen’s Health Research Group, in a statement.

The FDA stated that it will review the petition and intends to respond directly to Public Citizen.

Overview of Uloric Gout Treatment

According to the Mayo Clinic, gout is a type of arthritis caused by a metabolic imbalance, and often characterized by joint pain and flare ups.

This is caused by uric acid crystal buildup in the joints, kidneys, and other tissues, which can cause serious kidney disease if not properly treated. Uloric is one of the most popular treatment medications for gout in the United States, and works by lowering uric acid levels in the blood.

The gout drug Uloric was approved by the FDA in 2009, but the FDA had only approved the medication if Takeda Pharmaceuticals conducted a safety study to observe the medication’s potential side effects. It is important to note that when Uloric was approved, it already carried a warning regarding potential cardiac complications.

The FDA initially rejected Uloric in 2005 and 2006 due to concerns about potential cardiovascular episodes. During its second denial, the FDA pointed out that nine out of 12 patient deaths had been linked to Uloric while allopurinol patients and placebo patients did not experience any increased risks.

It is currently not known why the gout drug Uloric may be increasing the risk of potentially fatal cardiovascular episodes, but it is recommended that patients be vigilant for any signs of cardiac problems like chest pain.