New research and an FDA boxed warning suggest that the side effects of Uloric can include an increased risk for heart-related death and death from all causes.

What is Uloric?

Uloric (febuxostat) is a drug used to treat gout. It works by reducing the amount of uric acid in the blood, which reduces gout’s symptoms. 

What is Gout?

According to the Gout Education Society, a type of inflammatory arthritis, it’s believed that gout impacts up to 4 percent of the U.S. population. Gout frequently affects one joint at a time and is most often found in the big toe. However, gout can also be found in ankles, knees, and other toes. As uric acid builds up in the body due to diet or genetic issues, gout can develop.

Following a gout diagnosis, the doctor might recommend steps to prevent uric acid buildup, according to Medline. Lifestyle changes, pain management, and prescribing medicines such as Uloric can also be ways to address the condition.

Even though Uloric can help mitigate uric acid buildup, it can also lead to more serious medical conditions.

What are Uloric’s Side Effects?

A clinical trial conducted by the drug’s maker, Takeda, suggests that Uloric can increase a patient’s risk of death from a cardiac issue and can also increase the risk of death from all causes. The trial compared Uloric to another gout drug, allopurinol, which is sold under the brand names Zyloprim and Aloprim.

According to the U.S. Food and Drug Administration (FDA), “the primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring intervention, called unstable angina.”

Reportedly, when considered overall, Uloric did not increase the risk of these combined events, but when the outcomes were evaluated separately, there was an increase in Uloric heart-related deaths and deaths from all causes. 

The FDA says that symptoms related to heart conditions connected to Uloric include :

• Chest pain
• Shortness of breath
• Rapid or irregular heartbeat
• Numbness or weakness on one side of your body
• Dizziness
• Trouble talking
• Sudden severe headache

What is Being Done About the Risks for Uloric Side Effects?

In an effort to learn more about the possible risks associated with Uloric, the FDA has announced that it will conduct more research into both the elevated risk of heart-related deaths associated with the drug  and into the elevated risk of death from all causes.

Additionally, the FDA has added a boxed warning to the Uloric label. A boxed warning is is the FDA’s most prominent warning. The agency also says more information about risks associated with the drug will be included in a new patient medication guide. 

In an effort to limit the number of patients exposed to the possible health risks associated with Uloric, the medication is now limited to “certain patients who are not treated effectively or experience severe side effects with allopurinol.” 

Why was Uloric Approved?

Though 98.3 million adults in the U.S. suffer from gout, the number of medications available to treat the disease are limited. According to the FDA, the dearth of gout drugs resulted in an “unmet need” for gout treatment.

Uloric was approved in 2009 to treat gout because it was seen to effectively limit the amount of uric acid in the blood, which, in turn, can limit gout symptoms such as redness, swelling, and pain in one or multiple joints.

Even after receiving FDA approval, patients were warned about the drug’s possible cardiovascular events.  Research into the side effects of Uloric continues.

Common Uloric Lawsuit Claims

Increasingly, patients who have experienced an adverse reaction to Uloric have turned to lawyers for help filing injury claims. When a company is accused of failing to warn patients or doctors about possible problems, this can become the basis of a lawsuit.

Lawsuits filed by Uloric users say that Takeda Pharmaceuticals knew about the increased risk of death for those taking the medication but  failed to disclose the information.

Other patients have filed lawsuits after revelations that Uloric has been tied to other serious medical conditions, inclduing deep vein thrombosis, stroke, and pulmonary embolism.