According to the U.S. Food and Drug Administration, study results link the gout medication Uloric with heart attack causes and other sources of heart-related death.

The announcements came after Takeda Pharmaceuticals, the drug’s Chicago area-based manufacturer, released the results of the study. The study compared Uloric to allopurinol, another gout medication, sold under brand names Zylorprim and Aloprim. The preliminary study concluded that Uloric was also linked to various risks for heart related deaths, including deaths from heart attack causes and other etiologies.

Serious side effects associated with Uloric includes cardiac ischemia requiring immediate surgery, non-deadly heart attacks, and non-deadly strokes. Cardiac ischemia occurs when there is decreased blood supply to the heart.

Study Documents Possible Heart Attack Causes

The FDA’s two Drug Safety Communications were released advising of possible heart attack causes on Nov. 15, 2017. The FDA stated in their announcement that the “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.”

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.

Uloric became approved by the FDA in 2009. The trial continued for seven years, and patients that had been evaluated suffered from other conditions in addition to gout. Some had conditions including peripheral arterial disease, stroke, heart attack, diabetes, small vessel disease, and unstable angina.

According to the FDA’s announcement, “[h]ealth 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.”

Patients a part of an Uloric trial known as the CARES trial were randomly assigned. They were assigned one of the two gout medications, Uloric or allopurinol. Within a time- frame of 2.5 and 6.5 years, the medical health outcomes of the patients were tracked.

Researchers noted that 45 percent of patients taking Uloric discontinued the trial because of side effects. The study, principally investigated by the study’s lead author, William B. White, was published in the New England Journal of Medicine.

The two Drug Safety Communications state that while one would be evaluating the findings of increased heart-related deaths associated with Uloric, the second would be looking into Uloric side effects for its increase risks of death from all other causes.

Gout and Cardiac Ischemia

Gout is a condition that occurs with the buildup of excess uric acid. Attacks of gout include symptoms of redness, swelling, and pain. Uloric, as a gout medication, helps decrease bloodstream uric acid levels.

A cardiac or myocardial ischemia, according to the Mayo Clinic, results from deceased blood flow to the heart. Damage or disease to the body’s major blood vessels may lead to the development of cardiac ischemia with symptoms that include: shortness of breath when physically active; fatigue; shoulder to arm pain; sweating; nausea and vomiting; and neck or jaw pain.