Recent studies have shown that using Uloric for gout treatment may not be worth it for all patients.

Gout is a form of arthritis that occurs when the body fails to sufficiently process uric acid, a natural byproduct of cellular products. When uric acid builds up in the joints, it can form needle-like crystals which can lead to pain and inflammation. Gout often affects the base of the big toe, causing pain that is unbearable with the slightest pressure.

Uloric (febuxostat) is a gout medication that was approved in 2009 by the U.S. Food and Drug Administration (FDA). The drug aims to treat gout and prevent the buildup of uric acid by processing uric acid out of the body.

However, Uloric, or febuxostat, has been associated with various side effects including nausea, liver disease, an allergic reaction, and the more recently discovered risk of cardiovascular side effects.

The cardiovascular side effects of Uloric came to light in a large post-market safety trial conducted by Takeda Pharmaceuticals, the drug’s manufacturer. The trial compared outcomes of patients treated with either Uloric or allopurinol, another gout medication that has been associated with severe allergic reactions.

Post market trial data reportedly showed that there were 15 heart-related deaths and death from all causes per every 1,000 Uloric patients. In comparison, there were 11 heart-related deaths and death from all causes per every 1,000 patients treated with allopurinol.

The results of the trial prompted a warning from the FDA and further investigation into the issue. In February 2019, the FDA concluded that “there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol.” As a result of these conclusions, the FDA has updated Uloric prescribing information to include a boxed warning (the most prominent warning from the FDA) regarding heart related deaths.

Additionally, the FDA has decided to limit the approved usage of Uloric. Now, Uloric medication for gout treatment is only recommended for patients who have not been treated effectively or experience “severe side effects” with allopurinol.

“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 stated.

So, to answer the question: Is it safe to use Uloric medication for gout treatment? The short answer is maybe. Some patients will be treated with Uloric without any sort of side effects. However, others may be putting their life at risk to take the drug. Treatment decisions should be made on a personal basis and should always involve a medical professional.

Patients are encouraged to speak with their doctors about the risk and their own history of heart problems or stroke. They are also encouraged to seek medical treatment immediately if they experience chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, trouble talking, and a sudden severe headache while taking Uloric for gout treatment.

Does Gout Increase the Risk For Heart Disease?

According to a February 2017 blog posted by the Cleveland Heart Lab, up to 8 million Americans alone suffer from gout. A study published by the Annals of Rheumatic Diseases (ARD) is quoted in the post and purportedly indicates sufferers are at a very high risk of heart disease regardless of medication regimen.  The uric acid crystals which seek to settle in the joints—most commonly but not exclusively in that of the great toe—seems to spur the body to respond with inflammation.

This biological ‘feedback’ is a common precursor to the development of blood clots that impair or block circulatory flow and bring on respiratory or cardiac arrest or stroke. Although the academic discussion surrounding the link between gout and heart disease is far from new, the ARD study which operated out of a hospital in Spain examined a base of 247 patients with this common form of arthritis.

While all the participants were stratified for cardiovascular risk-based upon traditional lifestyle and familial questioning and common medical assessment tools, well over half of those enrolled in the study but not in a high-risk category had follow-up scans of carotid arteries. Half of these then were discovered to have a considerable build-up of plaque. Extrapolating from here, the researchers were able to determine those that initially tested as high risk were actually 68 percent more likely to develop heart disease than the standard population.

Double-backing to historical data collection, however, it was also noted by the Cleveland Heart Lab that the University of Oxford observed over a number of decades that a gout diagnosis increased the risk of heart attack or stroke twofold.