According to the FDA, Uloric, a medicine used to control arthritic gout, has been associated with potentially producing heart attack symptoms in an extensive cardiovascular-circulatory system post-market study whose results were released in March of this year.

The reported heart attack symptoms were primarily angina, a condition where a person experiences intense pain or tightening in the chest which can radiate to the neck, shoulders and upper arms.

What is Gout and Uloric?

Uloric, also known generically as febuxostat, is a product of Takeda, an international pharmaceutical company with a subsidiary in the Chicago area. It was approved by the U.S. Food and Drug Administration (FDA) in 2009 for the treatment of gout.

Gout is a type of arthritis characterized by extreme redness and joint pain in one or more joints—typically one of the big toes—and higher-than normal levels of uric acid in the blood. The build-up of uric acid in the blood associated with gout comes with crystalline formations which deposit into the tissues of certain joints.

The disease is more frequently diagnosed in men and, more often than not, is related to certain lifestyle factors such as excessive consumption of alcohol, red meats, poultry, and seafoods. There is also a genetic predisposition for the disease in some people.

Uloric competes commercially with a drug known as allopurinol. During Uloric’s initial clinical trials, it was found to slightly increase heart attack symptoms comparatively.

To be prudent, the FDA approved the new gout drug with the understanding that Chicago-based Takeda would undertake a long-term post-market safety study focusing on cardiovascular and circulatory effects. The study—whose data was released this Spring—had 50 percent of its subjects taking allopurinol as a control group.

The Two Gout Medications Compared

Allopurinol and Uloric performed in a very similar fashion, according to the CARES trial with 6,000 participants. The patients involved in the study—in order to best measure cardiovascular side effects of Uloric—all had a prior diagnosis of heart disease.

The heart disease had revealed itself in non-fatal heart attack symptoms like angina or actual cardiac arrest with a non-lethal outcome. Other indicators were previous stroke or peripheral artery disease (PAD)—a condition where there is inadequate blood flow to the extremities.

Although several of the participants did not see the study through to the end and it isn’t known if those that quit whether they remained on either drug, researchers reported that Uloric has a greater tendency to produce heart attack symptoms and cardiac arrest with a deadly outcome in patients previously diagnosed with heart disease.

This data was published in The New England Journal of Medicine in March 2018. Prior to this publication, it was the subject of safety warnings by the FDA last November which admitted the drug oversight agency would be further investigating the role of Uloric in cardiac and non-cardiac related deaths.

This communication was meant to alert medical professionals and the public concerning the potential dangers of the gout treatment medication. It recommended that physicians take care in thoroughly evaluating the patients for whom they prescribe the drug.