Uloric, a drug used to treat gout, has been part of a recent comparison study with its chief competitor allopurinol in which cardiac arrest symptoms and other cardiovascular strain of participants was heavily monitored.

Results from the Uloric post-market study were published in March 2017 and spurred the U.S. Food and Drug Administration (FDA)to release a safety warning to the public as well as the medical professional community in November of that same year.

The FDA warning indicated that cardiac arrest symptoms and other cardiovascular problems occurred more frequently in Uloric patients. The data gathered from the post-market study revealed that use of this particular gout treatment was connected to a higher risk of succumbing from a heart-related event such as heart attack.

The outcome of cardiac arrest symptoms or symptoms of stroke were not always fatal. Non-deadly heart attacks, strokes, and cardiac ischemia were also more common with this drug.

Gout and Heart Risk

It should be noted that cardiac problems including cardiac arrest symptoms can be part and parcel of having this particular type of arthritis. Gout is an inflammatory condition that usually reveals itself in a very painful, reddened condition of 1-2 joints, most typically that of the big toe. The painful condition is caused by crystalline deposits of uric acid which are abnormally high in the blood.

While there is a genetic and gender bias to gout—its can run in families and is more often diagnosed in males—it is commonly known as the disease of the affluent. This is not necessarily true, but consumption of a lot of foods that those of greater means can afford like red meats, wine or other alcohol, poultry, and seafood are contributing factors. This excess leads to obesity which also factors into the equation.

The History and Post-Market Comparison of Uloric

Early in 2009, Takeda Pharmaceuticals was successful in gaining FDA approval of Uloric and it was commercially released. Before its approval, however, there were some disturbing red flags that alerted the FDA to the need for greater follow-up in terms of the study of the drug’s effects.

Clinical trials showed an increased risk of experiencing cardiac arrest symptoms—which could be angina with its chest-tightening pain that radiates throughout chest, neck, shoulders, and arms—as well as actual cardiac arrests, strokes, and deaths from these events.

The federal drug and medical device oversight agency decided that post-market studies of Uloric were warranted to track this early pattern and see if it continued. After it was marketed, 6,000 gout patients were enrolled in a study where half were taking Uloric and the other half took allopurinol.

The half of enrollees taking Uloric experienced more cardiac arrest symptoms, fatal and non-fatal heart attack, and fatal and non-fatal stroke. Another noted increase was in the area of cardiac ischemia—a sudden drop in blood supply to the heart where surgery may be urgently needed to correct the problem.

It is never recommended to go off of a treatment regimen without first seeking the advice and guidance of your prescribing physician. If your are concerned about this information, make an appointment to discuss alternative medication.