The FDA recently issued a public warning regarding febuxostat CV risk, or cardiovascular risk, stating patients taking this medication are at risk for non-fatal cardiac events and potential cardiac death.

The FDA issued this warning after reviewing a study that compared febuxostat (Uloric) to allopurinol (Zyloprim and Aloprim), which indicated a higher risk for febuxostat CV risk.

The FDA issued two safety warnings regarding the study on Nov. 15, 2017. One stated that agency would be evaluating febuxostat CV risk, and the other stated it would be investigating all deaths potentially linked to the medication.

Along with febuxostat CV risk, the study also analyzed all other deaths that may have occurred in correlation with febuxostat prescriptions. The study found that febuxostat patients faced an increased risk of cardiac death and non fatal cardiovascular (CV) events including cardiac ischemia, stroke and heart attack.

The study was initiated after it was noted on the drug’s warning label that febuxostat carried an increased risk of cardiac related deaths. The FDA required Chicago area pharmaceutical company Takeda Pharmaceuticals to conduct a post-market study to further evaluate the risks.

The post-market study consisted of over 6,000 patients who were prescribed either febuxostat or allopurinol for gout treatment. The purpose of the study was to evaluate cardiovascular risks and other health problems.

The results showed an increased risk of cardiac related deaths and non-fatal heart attacks, stroke and cardiac ischemia. Ischemia occurs when blood flow to the heart decreases, which often requires prompt surgery to prevent further problems.

“The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. 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,” the FDA stated.

Overview of Febuxostat CV Risk

The FDA is set to conduct a comprehensive review of the post-market study, and will update the public when new information is available. The FDA is recommending healthcare professionals keep this study in mind when prescribing febuxostat, and that patients should talk to their physician before discontinuing the medication.

Febuxostat was approved by the FDA in 2009, and entered the market even though pre-clinical trials showed an increased risk for heart attacks and other cardiac related deaths. While these side effects are mentioned on the drug’s warning label, the FDA required Takeda Pharmaceuticals to perform post-market studies after the drug was released.

Febuxostat is commonly prescribed to treat gout, a specific type of arthritis that occurs when uric acid builds up and causes swelling and severe pain in the joints. Febuxostat works by reducing the level of uric acid in the blood, which helps treat the symptoms.

Even though febuxostat has helped numerous patients since its release, its association with cardiac related deaths is concerning to both the medical community and patient population.

A febuxostat lawsuit investigation has recently been launched for patients who may have been affected by febuxostat cardiac problems as well as increased febuxostat CV risk.