Preliminary results from a recent study were announced by the U.S. Food and Drug Administration (FDA), linking the gout medication Uloric to an increased rate of cardiac ischemia and other cardiovascular complications.

The study found that compared to another gout medication, Uloric was linked to a higher risk of heart-related death.

Uloric and Cardiac Ishemia

According to the FDA, Uloric is approved to treat an arthritic condition known as gout. Gout occurs when there is an excess of uric acid build-up that causes attacks of swelling, pain, and redness in the body’s joints. Uloric works to decrease uric acid levels in the blood.

According to the Mayo Clinic, cardiac or myocardial ischemia occurs when there is limited blood flow to the heart. It is the occurrence of damage or disease to the major blood vessels. A usual cause to insufficient blood flow with the heart is a complete or partial blockage. With limited supply of blood flow, the heart suffers from an insufficient supply of oxygen.

According to the Mayo Clinic, some symptoms of cardiac ischemia include shoulder to arm pain, nausea and vomiting, fatigue, sweating, a fast heartbeat, neck or jaw pain, and shortness of breath when physically active.

The safety communication announced by the FDA reported on preliminary results from the safety study. The communication that was announced on Nov. 15 advised that the FDA would assess results that correlated Uloric to increased risks for heart-related deaths in addition to death from all causes.

When the gout medication was first approved in 2009, the FDA mandated the drug’s manufacturer, Takeda Pharmaceuticals to administer a safety study. According to the FDA, that study was recently finalized, leaving the FDA to conduct a final comprehensive review of the results. The agency says it will update the public with new information as it becomes available.

Takeda Pharmaceuticals is one of the largest pharmaceutical companies in Japan and Asia. It has 15 subsidiaries world-wide one of which is based in the Chicago area.

Patients who participated in the mandated FDA safety trial were individuals with gout. More than 6,000 patients were treated with either allopurinol or Uloric. Complications reported with patients given Uloric include a combination of injuries such as nonfatal myocardial infarction, nonfatal stroke, cardiac ischemia needing immediate surgery, and heart-related death.

According to the FDA, “[t]he 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 FDA also advised health care professionals to consider this safety announcement when deliberating on whether to prescribe Uloric for gout treatment. The FDA also recommends patients to “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.”