A communication from the FDA says Takeda Uloric gout medication has been linked to increased instances of heart-related deaths and other severe complications.

The FDA’s announcement was based on a recent Uloric study that compared the medication to allopurinol, another gout medication. Uloric (febuxostat) was linked to more frequent heart side effects, including heart-related deaths. Reported side effects included non-deadly heart attacks, non-deadly strokes, and cardiac ischemia.

Overview: Takeda Uloric

Uloric was first approved by the FDA in 2009. It helps treat a condition known as gout, which results from an excess and build-up of uric acid that causes attacks of swelling, redness, and pain in the body’s joints. Uloric helps reduce uric acid levels in the bloodstream.

In addition to the FDA’s Nov. 15 safety announcement, the agency issued two other communications. The first advised that the agency would be evaluating heart-related death risks associated with Takeda Uloric, while the second advised that all other risks and causes for adverse side effects in addition to heart-related deaths would also be evaluated.

The FDA’s announcement for Takeda Uloric was made just after the drug’s manufacturer, Takeda Pharmaceuticals, released its findings. Results from the trial, which was comprised of almost 6,000 gout patients, found that there were increased risks for development of heart-related events and deaths from other causes in patients who took Uloric, compared to others who took allopurinol.

The FDA announcement advised health care professionals to take this information into account when prescribing Uloric. Patients are encouraged to raise any questions or concerns with their care providers, but they should not discontinue Uloric without proper medical supervision.

The combination of side effects found with Uloric included non-deadly heart attack, heart-related deaths, and, particularly, cardiac ischemia requiring immediate surgery. Cardiac ischemia occurs when there is decreased blood flow to the heart. Symptoms for its development can include shortness of breath when physically active, fatigue, shoulder or arm pain, sweating, nausea and vomiting, and neck or jaw pain.

According to the FDA’s announcement, “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.”

Termed the CARES trial, it first started in 2010 and continued for 7 years. The study spanned 320 centers in the U.S. It included patients with many varying conditions in addition to gout. Patients had histories of developments of peripheral arterial disease, stroke, heart attack, diabetes, small vessel disease, and unstable angina.

To assess the medication’s side effects, patients were randomly assigned one of two gout medications; allopurionol or Uloric. In a span of 2.5 to 6.5 years, patients’ medical health outcomes were tracked. Important to note, however, was that 45 percent of patients taking Uloric discontinued the trial. The study was investigated by the study’s lead author, William B. White, and later published by The New England Journal of Medicine.