The FDA has recently issued two warnings regarding Uloric adverse reactions after a study found that the gout medication could increase the risk of cardiac death in patients. The warnings were released after a study had compared Uloric adverse reactions to reactions in patients who were prescribed allopurinol.

The FDA issued two warnings on Nov. 15, 2017, with one stating it would be evaluating the increased risk of cardiac death in conjunction with Uloric adverse reactions. The second warning stated that it would be evaluating all potential causes of death related to Uloric, including cardiac related possibilities.

These announcements came after Takeda Pharmaceuticals had released the results of a clinical trial that showed a potential correlation between Uloric adverse effects and increased risk of cardiac death.

The study consisted of over 6,000 gout patients who were either prescribed Uloric or allopurinol, with the purpose of the study to evaluate the potential risks associated with the medication.

The study found that Uloric patients not only faced a greater risk of cardiac death, but also non-fatal stroke or heart attacks, and cardiac ischemia. Cardiac ischemia occurs when there is a decrease in blood supply to the heart, which may require urgent surgery to treat.

Cardiac complications can be caused by various problems including unhealthy diet choices, high stress levels, and other problems that can cause electrical disturbances in the heart. When this happens, the heart may be unable to pump blood through the circulation process, which can cause a multitude of problems including:

• Coronary Artery Disease
• Cardiomyopathy (heart muscles become enlarged or thickened, causing weak muscle)
• Long QT Syndrome and Brugada Syndrome (complications in the heart’s electrical activity, causing arrhythmia)
• Marfan Syndrome (a genetic disorder that causes parts of the heart to stretch and weaken)
• Cardiac Birth Defects

Due to the Uloric adverse effects being linked to a higher likelihood of cardiac death, patients may have to be wary of these complications.

Uloric was approved by the FDA in 2009 to be a treatment medication for gout, which is a type of arthritis that commonly affects the joints in the toes. Gout is caused by an overabundance of uric acid, which causes severe pain and swelling in one or more joints. Uloric works by lowering uric acid levels in the blood, which helps treat the symptoms.

At the time of the drug’s approval, initial trials had indicated that Uloric adverse effects may present an increased risk of heart attacks, stroke, and cardiac-related deaths. While these complications were included on the drug’s warning label, the FDA still required Takeda to perform a postmarket study to evaluate the potential Uloric adverse effects.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. [P]atients should talk to your healthcare 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.

Even with the post-market study results published and made available to the FDA, it has been alleged that Takeda Pharmaceuticals knew that increased risk of cardiac death could be caused by Uloric adverse effects.