The concern of Uloric heart attack risk has become very prominent in the United States, with Takeda Pharmaceuticals conducting a post market study exploring the correlation.

Uloric heart attack was a concern even before the medication was approved to enter the market, with the FDA requiring the Chicago-based pharmaceutical company to conduct the post market study.

The FDA recently issued two warnings regarding Uloric heart attack and other dangerous cardiac side effects on Nov. 15, 2017. One stated that the FDA would be evaluating the increased risk of cardiac related deaths linked to Uloric. The other warning stated that the agency would be reviewing all possible deaths linked to Uloric.

The FDA made these announcements after Takeda Pharmaceuticals released the results of a clinical trial that indicated an increased risk of Uloric heart attack and cardiac death compared to alternative gout medication allopurinol (sold as Zyloprim and Aloprim).

Other cardiac related complications in conjunction with Uloric include non fatal heart attacks, non fatal strokes, and cardiac ischemia requiring emergency surgery. Cardiac ischemia is a condition that reduces blood flow to the heart and may cause a stroke. These complications were also noted in the clinical trials also associated with Uloric heart attack.

The clinical trial included over 6,000 patients who were prescribed Uloric or allopurinol for gout treatment. The results of the study showed Uloric patients were significantly more likely to experience cardiac complications.

“Health care 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.

In addition to Uloric heart attack, the study is analyzing other potentially fatal risks that could be linked to the medication.

Overview of Uloric Heart Attack

Uloric was approved by the FDA in 2009, with pre clinical trials showing an increased risk of Uloric heat attack, strokes, and other cardiac related complications. While these problems were included on the drug’s warning label, the FDA required Takeda Pharmaceuticals to conduct an additional study after the medication was released into the market.

Uloric is prescribed to treat gout, which occurs when uric acid builds up and causes swelling the joints. Uloric works by reducing the level of uric acid in the blood, which prevents the swelling from spreading from beyond the swelling site. Uloric has been prescribed to numerous patients since its approval, but the correlation to cardiac complications is very troubling.

At this point, it is not known why the drug’s treatment mechanism may be inducing Uloric heart attack. Patients who have a family history of cardiac complications or sensitivity to cardiac problems, may be at higher risk for Uloric heart attack.

Even though Uloric heart attack can be potentially deadly to patients, Takeda Pharmaceuticals may not have adequately warned patients against this correlation. Takeda Pharmaceuticals faced a whistleblower lawsuit filed in 2012, filed by a former company safety consultant who alleged the pharmaceutical company had concealed vital drug safety information from the federal government.