The gout drug Uloric has been linked to a number of serious complications leading the U.S. Food and Drug Administration (FDA) to issue a recent warning announcement advising of the drug’s side effects.

According to the FDA’s report based off preliminary results from a safety clinic trial, Uloric may increase the likelihood of heart-related deaths and other cardiovascular side effects, they state.

The trial showed an increased risk of heart-related deaths in comparison to allopurinol, sold under brand names Aloprim and Zyloprim. Heart related side effects also include cardiac ischemia, non-deadly heart attacks and non-deadly strokes.

Overview: Gout Drug Uloric

The gout drug Uloric (febuxostat) was first approved by the FDA in 2009. It was prescribed to treat gout, a condition that occurs when there is excess uric acid buildup that leads to swelling, redness and pain in the body’s joints. Uloric helps reduce uric acid levels in the bloodstream.

When the drug was approved in 2009, the FDA required Takeda Pharmaceuticals, Uloric’s manufacturer, to conduct the safety trial because of the increased risks for heart-related complications associated with this drug.

The clinical trial was recently completed and is awaiting the FDA’s comprehensive review and public update with the final results. Uloric, however, already includes precautionary warnings about cardiovascular events linked to the medication.

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 announcement also advised health care professionals to deliberate carefully when prescribing Uloric for patient treatment. The agency also 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.”

More than 6,000 people were examined during the safety trial. Known as the CARES trial, it began in 2010 and examined people who were treated with either Uloric or allopurinol. Primary outcomes for those on the medication included non-deadly heart attack, non-deadly stroke, heart-related death, and a condition that includes insufficient blood supply to the heart requiring immediate surgery.

The study lasted for seven years and incorporated approximately 320 centers throughout the U.S. Patients with various medical conditions were also seen. Conditions included peripheral arterial disease, stroke, heart attack, diabetes, small vessel disease and unstable angina.

During the trial, patients 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, according to preliminary results, 45 percent of patients who were randomly assigned Uloric decided not to continue on with the trial due to adverse side effects they suffered.

In 2012, Uloric was also the subject of a whistleblower lawsuit filed by a former Takeda Pharmaceuticals consultant who accused the company of hiding pertinent information regarding the drug’s adverse side effects from the federal government.