The FDA has recently issued a public warning regarding the risk Uloric cardiac arrest, after a recent post marketing study had linked the medication to fatal and non-fatal cardiac episodes.

Uloric is typically prescribed to treat gout, a type of arthritis caused by the buildup of uric acid and causes pain and swelling in joints.

The concern of Uloric cardiac arrest was present before the medication was even approved, with initial pre-market studies showing a potential correlation between heart attacks and other cardiac related deaths.

The concern of Uloric cardiac arrest stems back from when it first entered the market in 2009, when the Chicago based manufacturer Takeda Pharmaceuticals had stated initial clinical trials had shown an increased risk of heart attack and cardiac related deaths on the drug’s warning label.

Due to these initial findings, the FDA required Takeda Pharmaceuticals, Uloric’s Chicago area-based manufacturer, to perform a post-market study soon after the drug was released.

Overview of Uloric Cardiac Arrest

The post market study compared the risk of Uloric cardiac arrest to other gout medication allopurinol (brand names Zyloprim and Aloprim), with researchers finding a significant increase of cardiac episodes in Uloric patients.

In addition to potentially fatal Uloric cardiac arrest taking place, researchers also found an increased risk of non fatal heart attacks and stroke and cardiac ischemia, which requires emergency surgery to resolve.

The post market trial observed over 6,000 gout patients who either prescribed Uloric or allopurinol, with the outcome of the study showing that there could be an increased risk for Uloric cardiac arrest and other cardiac episodes like ischemia.

Cardiac ischemia occurs when the blood supply to the heart decreases, which can be potentially fatal if left untreated. The post market study left the FDA very concerned, and the agency released two Drug Safety Communications on Nov. 15, 2017.

The first communication stated the FDA would be evaluating whether or not there is an increased risk of Uloric cardiac arrest and other cardiac related deaths potentially linked to the medication. The second communication stated that the FDA would be evaluated all deaths potentially linked to Uloric.

The FDA further stated that medical professionals should consider potential Uloric side effects, before deciding whether or not to prescribe Uloric.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. [P]atients 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,” the FDA stated.

Numerous patients are prescribed Uloric to treat gout, with many of them most likely not aware of the risk for cardiac related incidents. The severity of Uloric cardiac arrest had become public interest when they were pointed out in a 2012 whistleblower lawsuit that was filed by a former Takeda safety consultant.

The claim alleged Takeda did not sufficiently warn the federal government against Uloric side effects. A class action investigation was recently launched, which may allow patients who could have suffered Uloric cardiac arrest or other damages to seek compensation.