The U.S. Food and Drug Administration (FDA) made a recent announcement that results from a preliminary study found an increased risk for cardiac ischemia with the gout drug febuxostat (Uloric).

According to the study, the gout drug febuxostat was also linked to various other risks for heart related death.

The preliminary study compared the gout drug febuxostat with another gout medication, allopurinol, sold under brand names Aloprim and Zylorprim. They found that Ulroic increased risk for heart-related death as well as deaths from all causes.

Some serious side effects linked to Uloric includes non-deadly strokes, cardiac ischemia requiring immediate surgery, and non-deadly heart attacks.

Gout Drug Febuxostat Facts

The gout drug febuxostat, also known as Uloric, became approved by the FDA to treat the arthritic condition known as gout in adults. Gout occurs through the build-up of uric acid which causes attacks of swelling, redness and pain in the body’s joints. Ulroic works by reducing 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, or by the complete or partial blockage of those vessels. With not enough oxygen because of the limited supply of blood flow, the muscle suffers.

Symptoms of cardiac ischemia, according to the Mayo Clinic, may include the following: shortness of breath when physically active; fatigue; shoulder to arm pain; sweating; nausea and vomiting and neck or jaw pain.

When Uloric first became approved by the FDA, the federal agency required the drug’s manufacturers, Takeda Pharmaceuticals, to administer an additional safety study. With more than 15 pharmaceutical companies worldwide, with one based in the Chicago area, Takeda Pharmaceuticals in one of the largest pharmaceutical companies in Japan and Asia.

The FDA announced the results of the preliminary study in an announcement made on Nov. 15. They further indicated that along with the preliminary results, they would assess the results which linked Uloric to risks for heart-related deaths and deaths from all causes.

The mandated FDA safety trial consisted of 6,000 individuals who had gout. The patients were treated with either allopurinol or Uloric. However, more adverse effects were found with those that were given Uloric than with those being treated with allopurinol.

Some of the side effects associated with the gout drug febuxostat included a combination of injuries such as nonfatal stroke, nonfatal myocardial infarction, cardiac ischemia requiring immediate surgery and heart-related death.

According to the FDA, “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.”

With the outcome from the preliminary study, the announcement by the FDA advised health care professionals to carefully deliberate whether to prescribe the gout drug febuxostat for patient treatment.

According to the FDA, the federal agencies advises 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.”