Patients who take the gout drug Uloric may be at risk for deadly heart conditions including Uloric cardiac arrest, the U.S. Food and Drug Administration (FDA) recently warned.

In 2009, the FDA approved Uloric, generically known as febuxostat. It is a xanthine oxidase inhibitor intended to reduce the amount of uric acid in a patient’s body by inhibiting its production.

According to the Mayo Clinic, gout is a condition in which a patient’s body has too much uric acid in the blood. Uric acid is naturally produced by the body as it breaks down purines, which are substances found in certain foods such as steak, organ meats, and seafood.

Normally, uric acid is dissolved in the blood and processed out of the body through the kidneys. In patients with gout, uric acid is either overproduced or is insufficiently processed out of the body. This results in a build-up of the uric acid in the joints where the acid then forms sharp, needle-like crystals that can irritate the surrounding tissue.

Gout is technically classified as a form of inflammatory arthritis that causes a patient’s joints to experience sudden and severe pain and swelling. The big toe is the most common joint affected by gout symptoms but other joints in the body can also be impacted.

The FDA released a set of Uloric warnings recently that connected the gout medication to an increase in Uloric cardiac arrest deaths when compared to other gout medications including Zyloprim and Aloprim.

Takeda Pharmaceuticals, the company that manufactures Uloric, released the results of a study it performed comparing Uloric with allopurinol. Allopurinol is another gout medication that received bad press after being linked to severe allergic reactions.

Takeda Pharmaceuticals is the largest pharmaceutical company in Japan and among the top 15 pharmaceutical manufacturers in the world. It makes and distributes at least 24 drugs in the United States.

The Takeda study found an increase in Uloric related heart condition fatalities associated with the medication. These included non-fatal heart attacks, non-fatal strokes, and cardiac ischemia. Ischemia is a decreased blood supply to the heart.

This clinical trial studied 6,000 patients who suffered from gout and were taking either Uloric or allopurinol. According to Takeda’s results, it showed an increase in certain heart conditions in the patients taking Uloric. These heart conditions included potentially deadly Uloric side effects.

On Nov. 15, 2017, the FDA released its reports of Takeda’s Uloric clinical trial results. The FDA noted in its first communication that it would be looking at Uloric cardiac arrest deaths, and a second report said it would be looking at all Uloric-related deaths, including deaths from heart conditions.

When Uloric was first released, it included a warning on its label warning of heart-related deaths. At the time of the drug’s FDA approval, the agency asked the drug’s manufacturers to look at Uloric cardiac arrest deaths and other heart-related complications associated with Uloric.

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

Additionally, the FDA has recommendations for both patients and healthcare professionals regarding the risk of Uloric cardiac arrest complications. “Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. Patients should talk to your health care professionals if you have any questions or concerns.”

In February 2019, Pharmacy Times reported that due to the evidence of increased cardiovascular deaths with Uloric, the FDA added a boxed warning to Uloric’s labeling. The boxed warning is the FDA’s most severe warning and, on the Uloric packaging, will serve to warn patients and doctors of the risks for heart- related death.

“This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric,” the FDA said in a statement.

The FDA has also limited the usage of Uloric to only include patients who experience severe side effects with allopurinol or are not being effectively treated with the drug. The agency limits approved usage in situations where it hopes to decrease the number of patients who experience adverse side effects.

If you or someone you love has experienced serious heart-related conditions as a result of taking Uloric, you may benefit from speaking to an experienced attorney.

While a lawsuit may not be able to bring a loved one back to life or take away the pain and suffering caused by serious complications, it may help to alleviate the financial strain of hospital bills or lost wages.