A Uloric FDA alert says the gout medication is linked to heart-related complications including heart attack, stroke, hospitalization for chest pain, and heart-related deaths.

Uloric, also known by its generic name febuxostat, is a common prescription drug used to treat gout. Gout is a form of arthritis that develops when uric acid builds up in joints, causing severe pain, redness, and inflammation.

Uloric treats gout by lowering uric acid levels in a patient’s blood. However, new studies suggest that the drug may do more harm than good. The drug’s maker, Takeda Pharmaceuticals, recently released the results of a clinical trial examining the health effects of the drug. According to the study, Uloric reportedly has a higher mortality rate than an alternative gout medication, allopurinol, especially in the case of heart-related deaths.

The risk of cardiac events was consistent among groups studied, according to the study findings, and all demographic groups had an equally elevated risk of developing cardiac problems as a result of using Uloric.

As a result of these preliminary findings, a Uloric FDA alert was released, warning consumers about the dangers of the gout medication. The Uloric FDA alert says that patients should be aware that the drug is linked to cardiac side effects, and that patients who already have a history of heart disease and cardiac events should be especially cautious when taking the drug.

Uloric was initially approved in 2009. At that time, no study linked Uloric to cardiac problems. The drug was marketed as safe and effective — better than existing gout drugs on the market. However, new information about the potential impacts of the drug has been released, suggesting that the drug does not live up to its advertised benefits.

Uloric FDA Alert

The Uloric FDA alert is based on a study that began in 2010, after the drug was already on the market. In this study, Uloric was seen to have a higher mortality rate than allopurinol. The study examined the effect of the drug on a patient’s cardiac health, especially in patients who already had heart problems. 

Many patients dropped out of the study, making drawing conclusions more challenging. However, those patients who dropped out reportedly decreased their mortality risk when they stopped taking Uloric.

The study also examined the effects of Uloric on patients with both cardiovascular and kidney disease. Though Uloric was initially marketed as a healthier alternative to allopurinol, which had been linked to kidney problems in African American patients, the findings of the study did not support this claim. In fact, no significant difference was found between the kidney-related mortality rate of allopurinol and that of Uloric.

The information currently available from the new study is still under evaluation by the FDA, and, after publishing the Uloric FDA alert, the FDA will reportedly continue to investigate the optimal treatment for gout that poses the least risk to patient health.