Uloric heart diseasecould be a risk for gout patients, according to an announcement by the U.S. Food and Drug Administration (FDA). The findings are based on a preliminary study of the gout medication.

The results from the study found Uloric (febuxostat) was linked to the development of non-deadly heart attacks and non-deadly strokes among patients at increased risk for cardiac ischemia. Cardiac ischemia occurs with a decreased supply of blood to the heart. The development of cardiac ischemia may require immediate surgery.

The study compared Uloric to allopurinol, sold under brand names Zylorprim and Aloprim. The announcement by the FDA was made after results were released by the drug’s manufacturer, Chicago-based Takeda Pharmaceuticals. Other heart related deaths, including deaths from all causes, were found linked to Uloric.

Overview: Uloric Heart Disease

Uloric was approved by the FDA in 2009. The preliminary trial, known as the CARES trial, began in 2010 and evaluated more than 6,000 patients who developed gout across 320 U.S. centers.

Gout occurs when there is a buildup and excess of uric acid. Symptoms may include swelling, pain, and redness. Uloric helps decrease uric acid levels in the bloodstream.

The FDA’s two Drug Safety Communications based off the CARES trial were released on Nov. 15, 2017 advising of heart related side effects. One communication advised that the FDA would be evaluating increased risk of heart-related deaths to Ulroic, while the second would be looking into deaths from other causes in addition to heart-related deaths.

According to the FDA’s announcement, “preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”

Uloric heart disease may include cardiac or myocardial ischemia. Cardiac ischemia may result from damage or disease to the body’s major blood vessel. Symptoms of cardiac ischemia includes shortness of breath when physically active, fatigue, shoulder to arm pain, sweating, nausea and vomiting, and neck or jaw pain.

The results of the CARES trial led the FDA to also iterate that “Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”

During the CARES trial, patients were randomly assigned and the trial continued for seven years. Each patient was randomly assigned one of the two gout medications, Uloric or allopurinol. All patients a part of the study possessed a gout condition. Some even had other conditions such as peripheral arterial disease, diabetes, small vessel disease, unstable angina, and had suffered from a heart attack or stroke.

Patient outcomes were tracked between 2.5 and 6.5 years. However, 45 percent of patients taking Uloric discontinued to the trial due to adverse side effects and complications. The study was principally investigated by the study’s lead author, William B. White, and was published in the New England Journal of Medicine.