An announcement was recently made by the U.S. Food and Drug Administration (FDA) that increased heart-related deaths and other Uloric side effects are linked to Uloric (febuxostat), a gout medication.

The FDA’s announcement was based off a recent study that compared Uloric to allopurinol, also a gout medication but sold under brand names Aloprim and Zyloprim. The study found that there are increased Uloric side effects, including death risks for patients that take Uloric.

Uloric side effects also linked to the medication include cardiac ischemia, non-deadly heart attacks and non-deadly strokes.

Overview: Uloric Side Effects

Two Drug Safety Communications were released by the FDA on Nov. 15.  One safety communication iterated that the FDA would be evaluating the findings of increased heart-related deaths associated with Uloric, while the second Drug Safety Communication stated that it would be looking into Uloric side effects for its increase risks of death from all other causes.

The study was published in the New England Journal of Medicine and was principally investigated by William B. White, the study’s lead author. Specifically, the study found that in patients taking Uloric there were increased risks for death for those that had already had a heart-related condition such as heart disease in comparison to another drug, allopurinol.

The study also discovered, however, that the two drugs were similar when it came to causing adverse side effects such as nonfatal heart attack, nonfatal stroke, urgent surgery for angina treatment and death due to cardiovascular causes.

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.”

The FDA’s announcement advises health care professionals to carefully deliberate whether to describe Uloric for patient treatment. According to the FDA, they advised 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.”

The CARES trial began in 2010 and continued for seven years. The study evaluated more than 6,000 patients with gout across 320 centers in the United States. Patients that were a part of the study possessed a variety of conditions, not only gout. Some were suffering from peripheral arterial disease, stroke, heart attack, diabetes, small vessel disease and unstable angina.

Patients in the study were randomly assigned either one of the two gout medications. Within 2.5 and 6.5 years, patients’ medical health outcomes were tracked. However, according to the study, 45% of patients taking Uloric discontinued the trial.

Gout is a condition that occurs with the excess and build-up of uric acid that causes attacks of swelling, redness, and pain in the body’s joints. Uloric, approved by the FDA in 2009, helps reduce uric acid levels in the bloodstream.

According to the Mayo Clinic, a cardiac or myocardial ischemia is the result of decreased blood flow to the heart. It results from damage or disease to the body’s major blood vessels, and with the decreased flow of oxygen, a muscle may suffer.

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.