The gout medicine Uloric has been linked to an increased risk of cardiac related deaths in a recent study, spurring the FDA to issue a new warning.

The study compared the gout medicine Uloric to allopurinol, sold under the brands Zyloprim and Aloprim, and observed the number of patients who  developed cardiac complications and fatalities possibly linked to the medications.

The gout medicine Uloric was approved by the FDA in 2009, and works by reducing the level of uric acid in the blood. Gout is a variant of arthritis that affects one or multiple joints, often causing redness and swelling, making daily life difficult for patients.

It is important to note that Uloric was the first medication to be approved for gout treatment purposes in 40 years, with nearly four percent of adults in the United States suffering from gout attacks.

Even though Uloric has helped many gout patients, there have been concerns surrounding the medication since its release due to early clinical trial results.

According to initial clinical studies, patients who were prescribed the gout medicine Uloric showed an increased likelihood of developing heart attacks, strokes, and cardiac related deaths.

While these complications are mentioned on the drug’s warning label, the FDA required manufacturer Takeda Pharmaceuticals to perform a follow up study after Uloric was released.

Overview of Increased Uloric Cardiovascular Death Risk

The clinical trial consisted of over 6,000 patients who were either prescribed the gout medicine Uloric or allopurinol, with researchers observing the side effects patients experienced.

According to the study, Uloric patients experienced a higher risk of cardiac related deaths, non fatal heart attacks and strokes and cardiac ischemia. Ischemia occurs when there is a decrease in blood supply to the heart, and often requires urgent surgery.

Recently, the CARES clinical trial results were announced at the American College of Cardiology’s 67th Annual Scientific session with lead investigator and author Dr. William B. White presenting the results. Dr. White stated that he and his colleagues were surprised that Uloric increased the risk of cardiovascular deaths, but not an increased risk of non-fatal heart attacks.

The results of the study prompted the FDA to issue two safety warnings on Nov. 15, 2017, with the first warning stating that it would be evaluating the potential increased risk of cardiac related deaths in conjunction with the gout medicine Uloric.

The second warning stated that the FDA would also be looking into all other deaths, including cardiac deaths, which were potentially caused by 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.

Even though the FDA recently warned against the possible correlation, Takeda allegedly knew about the increase in cardiac deaths for years.

According to a whistleblower lawsuit filed in 2012 by a former Takeda safety consultant, the drug company hid vital safety information regarding the drug’s side effects from the federal government.