Uloric, as a prescribed drug for the condition known as gout, had clinic trial data connected with it that was concerning from the very beginning.

The U.S. Food and Drug Administration (FDA) approved the gout medication in 2009 with a label warning about the possibility of Uloric heart attack, stroke, and cardiac ischemia.

The agency also demanded that the drug’s manufacturer, Chicago-based Taketa Pharmaceuticals, do a post-market follow-up study to verify these initially identified risks.

In a recent safety-related press release in November 2017, the FDA indicated that of 6,000 patients involved in the required follow-up study, half were placed on Uloric (identified by its generic name febuxostat) and half were prescribed allopurinol. Allopurinol is a competing treatment drug for gout. Uloric did not reveal an overall increase in the risk of death from Uloric heart attack, stroke, or risk of non-deadly cardiac events when compared to this competitor.

The FDA did say, however, that when the results of this study were evaluated closely and separately from the allopurinol control group, it did show an increased risk of death occurring from Uloric heart attack, critical heart ischemia—a condition of reduced blood flow and resultant oxygen to the cardiac muscle—and stroke.

In addition to indicating an increased risk of Uloric heart attack and other serious heart events when evaluated separately, the study revealed a statistically significant risk of dying from all causes while taking the drug.

Because of this study, the FDA will be continuing to keep its eye on adverse event reports regarding this drug. In the meantime, it has encouraged medical professionals to be careful and consider all risk factors such as obesity, smoking, the presence of Diabetes or other concurrent illnesses when deciding upon a course of treatment for gout with patients.

At this time, the label on febuxostat will remain as it was from its initial 2009 approval—warning consumers of the potential of a Uloric heart attack while on the drug.

What is Gout?

Gout is an arthritic condition usually treated by specialty doctors known as rheumatologists. It is caused by a build-up of uric acid in the body and reveals itself through painful inflammation and redness in one or more joints. The uric acid build-up forms crystals in the affected joint which is, although not always, one of the big toes. While it may start in one joint, it can spread to others and cause widespread joint damage.

Gout attacks men more often than women and typically come on after the mid-forties and beyond. Statistically speaking, women catch up with men in developing gout symptoms after menopause. Gout has been often referred to as the disease of ‘rich-living’ as some of the risk factors include a diet filled with red meat and organ meat as well as alcohol.

Consumption of foods containing large amounts of high-fructose corn syrup can also contribute to its onset. It can also happen, however, because of other health conditions such as kidney disease, diabetes, high blood pressure and heart disease or familial genetic tendencies.