According to an announcement made by the U.S. Food and Drug Administration (FDA), released results from a preliminary study found an increased risk of Uloric cardiac ischemia associated with the gout medication.

According to the study, researchers discovered that patients taking Uloric (febuxostat) also developed increased risks for heart-related death from the medication. The study compared Uloric to a second gout medication, allopurinol, sold under brand names Zyloprim and Aloprim. Some patients reported Uloric cardiac ischemia, prompting further investigation.

Uloric Cardiac Ischemia

Uloric, approved by the FDA in 2009, is prescribed for the treatment of an arthritic condition known as gout. Uloric and allopurinol work by decreasing uric acid levels in the blood that can cause attacks of swelling, pain, and redness in the joints.

However, when the FDA first approved the medication, they required the drug’s manufacturing company, Takeda Pharmaceuticals, based in the Chicago area, to administer additional safety studies.

The FDA reported on the findings and preliminary results of the safety study in an announcement made on Nov. 15. The results communicated that Uloric had been linked to increased risks for heart-related deaths as well as deaths from all causes. Other serious Uloric cardiac ischemia side effects included the development of non-deadly heart attacks, non-deadly strokes, and cardiac ischemia that require immediate surgery.

According to the communication, the FDA warned that “[h]ealthcare professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat.”

“Patients should talk to your healthcare professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your healthcare professional.”

According to the Mayo Clinic, Uloric cardiac ischemia occurs when there is a limited amount of blood flow to the heart. This may result due to damage or disease of the major blood vessels, that can come about from a partial or complete blockage. Some symptoms of cardiac ischemia include nausea and vomiting; fatigue; sweating; shoulder to arm pain; neck or jaw pain; fast heartbeat; and shortness of breath.

The mandated FDA clinical trial composed of approximately 6,000 patients with gout who were medicated with either allopurinol or Uloric. The outcome of the trial found that adverse effects were more closely associated with patients taking Uloric than with those taking allopurinol.

Uloric Whistleblower Lawsuit

In 2012, a former employee working for Takeda as a safety consultant reported on adverse side effects that the company hid from the public and the federal government. When combined with drugs, such as Imuran, methadone, warfarin, and digoxin, it allows for potentially deadly and fatal side effects, the whistleblower lawsuit reported. The failure to report these warnings has allegedly led to multiple patient deaths.

Among other accusations alleged in the whistleblower lawsuit, Takeda was accused of failing to report Uloric’s risk for the development of bone marrow failure, kidney failure, and severe bleeding. The whistleblower lawsuit alleged that when Takeda reportedly sent documents over to the FDA, the company falsified claims and made Uloric seem a lot safer than it was.

Some of these actions were allegedly carried out by Takeda because of the price difference between allopurinol and Uloric. Whereas the drug allopurinol costs a mere 10 cents per day on the manufacturer’s end, patients taking Uloric are made to pay $5 per day, thus adding to Takeda’s total pharmaceutical revenue and sales.