Many complications and side effects of Uloric have been linked to the popular gout medication, leading the U.S. Food and Drug Administration (FDA) to issue a recent warning announcement concerning the drug’s side effects.

According to the recent announcement made by the FDA, they advised that side effects of Uloric (febuxostat) included links to increased heart-related deaths. This announcement was made in accordance with a recent study conducted that compared Uloric to allopurinol. Allopurinol is sold under the brand names Aloprim and Zyloprim.

Other side effects of Uloric have included cardiac ischemia, non-deadly heart attacks, and non-deadly strokes.

Overview: Side Effects of Uloric

Uloric, a gout medication produced by Takeda Pharmaceuticals in Chicago, first became approved by the FDA in 2009. Gout is a medical condition that occurs when there is excess uric-acid buildup that leads to attacks of swelling, redness, and pain in the body’s joints. Taking Uloric helps reduce uric acid levels in the bloodstream.

The FDA released two Drug Safety Communications on Nov. 15,  2017. According to one Safety Communication, it announced that it would be further investigating the findings of heart-related deaths associated with Uloric, while the second affirmed that it would be looking into side effects of Uloric and its increased risk of death from all other causes.

The Uloric-Allopurinol study that led to the discovery of an increase in the risk of heart-related events and death from all other causes was principally investigated by William B. White and published in the New England Journal of Medicine. The study also discovered, however, the similarities between the two drugs when it came to causing adverse side effects such as nonfatal stroke, nonfatal heart attack, death due to cardiovascular causes, and angina treatment.

The study, dubbed the CARES trial, began in 2010 and lasted for seven years evaluating more than 6,000 patients. The trial incorporated roughly 320 centers throughout the U.S. and patients with various conditions, not only gout, were a part of the trial. Patients suffered varying conditions including peripheral arterial disease, stroke, heart attack, diabetes, small vessel disease, and unstable angina.

Patients included as part of the CARES trial were randomly assigned one of the two gout medications, allopurinol or Uloric. Patient medical outcomes were thoroughly tracked within the span of 2.5 and 6.5 years. However, 45% of patients randomly assigned Uloric, according to the study, decided to discontinue the trial.

The FDA stated in their recent announcement that “[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 announcement advised health care professionals to deliberate carefully when prescribing Uloric for patient treatment. The agency also advised patients to talk to their health care professionals if they have any questions or concerns. As with most medications, do not stop taking the medicine without first consulting with your health care professional.