The popular Uloric medication for gout has recently been linked to increased risk of cardiac deaths, with the FDA releasing an official warning regarding recent reports.

Even though Uloric has treated millions of patients, this alleged link is causing concern in the medical community and patient population.

Uloric medication for gout was approved by the FDA in 2009. It had shown evidence of risk for cardiac events during early clinical trials.

While this information is included on the drug’s warning label, the FDA still released public safety announcements after Takeda Pharmaceuticals released the results of their post market study. The FDA had required Takeda Pharmaceuticals to perform this additional study due to the results of the earlier study.

Overview of Uloric Cardiac Attack Correlation

The FDA issued an official warning for the alleged link on Nov. 15, 2017, with the agency stating it would be evaluating the risk-safety profile of the drug.

The FDA was spurred into action after a recent study found an increased risk of cardiac death in conjunction with the Uloric medication for gout. The study compared Uloric (febuxostat) to allopurinol (brand names Zyloprim and Aloprim), in which the control group did not face an increased risk of cardiac death.

Uloric has also been linked to non-fatal heart attacks, non-fatal strokes, and cardiac ischemia that requires emergency surgery. The FDA also released another warning regarding Uloric medication for gout, with the agency stating that will be evaluating all alleged fatalities linked to the drug.

These FDA warnings were released after Uloric manufacturer Takeda Pharmaceuticals released the results of a clinical study that found an increased risk of fatal cardiac attacks in conjunction with Uloric prescriptions. The study compared the Uloric medication for gout to allopurinol, consisting of 6,000 patients who were prescribed either of these drugs for treatment.

The outcome of the study showed Uloric patients experienced increased risks for a variety of cardiac events, with some patients reporting potentially fatal episodes. The results of the study have called for further investigation, with the FDA advising physicians to consider other options before prescribing Uloric.

Gout is a painful type of arthritis in one or more joints often characterized by swelling, redness, debilitating pain, and is a very common ailment. This condition is caused by buildup of uric acid, with Uloric and allopurinol used to lower blood acidity levels and to reduce the swelling.

Even though the Uloric medication for gout is commonly used throughout the country, it is important for prescribing physicians to discuss all potential side effects of medications they may potentially prescribe to their patients.

“Healthcare professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. [P]atients should 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 FDA stated.

Patients who may have suffered a cardiac episode soon after starting their Uloric medication for gout may be able to join an ongoing class action investigation.