Earlier this year, the U.S. Food and Drug Administration (FDA) took decisive action after an “in-depth review of a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric,” a medication prescribed to treat gout.

Researchers found a link between febuxostat (Uloric) and an increased risk of cardiac death according to study results published by the American College of Cardiology in May 2018.

The study’s researchers looked at 6,000 gout patients with established cardiovascular disease who had used febuxostat. They found that these people faced an increased likelihood of suffering non-fatal heart attacks, stroke, and cardiac ischemia requiring emergency surgery. Cardiac ischemia occurs when there is insufficient blood supply to the heart, which can be fatal if not treated.

The researchers compared febuxostat used for gout treatment with patients who were prescribed allopurinol.

The FDA reviewed the study and promised it would evaluate whether or not febuxostat increased the risk of cardiac death, as well as all deaths, potentially associated with the drug. In February, the agency ordered a new boxed warning be placed on the label for Uloric.

These warnings prompted questions from both the general public and the medical community:

What is Febuxostat?

Febuxostat is a gout medication approved by the FDA in 2009.

It’s important to note that the FDA required Takeda Pharmaceuticals to conduct a clinical study as a condition for the drug’s release, reportedly because preclinical trials indicated the medication could increase the likelihood of certain cardiovascular complications.

What is Febuxostat Used For?

Febuxostat’s primary use is to treat gout in adult patients. It works by lowering the uric acid levels in the blood.

According to the Johns Hopkins Arthritis Center, gout is a form of arthritis that affects the joints and is caused by a buildup of uric acid. Uric acid typically comes from substances called purines, but can also be caused from unhealthy food and drink choices.

What are the Side Effects of Febuxostat?

The most common side effects of febuxostat include, but are not limited to:

• Liver complications (upper right pain in stomach, fatigue, dark urine, or jaundice)
• Nausea
• Gout flares
• Joint pain
• Rash

However, it has been repeatedly noted that febuxostat is associated with an increased risk of cardiac death, and fatality risk overall.

While an increased risk of heart attacks, strokes, and other cardiac related deaths are included on the drug’s warning label, the FDA required Takeda to perform a study after febuxostat’s release  in order to further evaluate this risk. According to EMedicine Health, signs of febuxostat cardiovascular problems include:

• Heart attack symptoms: chest pain or pressure, pain spreading in jaw or shoulders, nausea, and sweating
• Stroke symptoms: sudden numbness or weakness on one side of the body, sudden severe headache, slurred speech, and problems with vision and balance

How Does Febuxostat Increase the Risk of Cardiac Death?

The mechanism for how febuxostat may increase the risk of cardiac death, or the chances of death overall, is currently unknown.

For now, the FDA is warning doctors to evaluate the potential side effects before prescribing febuxostat to patients. Patients are advised to talk to their doctors about any concerns. However, it is important that patients continue taking their medication unless their physician tells them otherwise.