The FDA is concerned about patients who take the gout medication Uloric because of the risk of Uloric heart related deaths.

In the last year, the U.S. Food and Drug Administration (FDA) sent out a safety communication warning the public about Uloric heart related deaths.

This FDA warning, issued on Nov. 15, 2017, notes that upon reviewing a recent study, they have determined that taking Uloric gout medication may lead to an increased risk of Uloric heart-related death.

When the FDA approved Uloric in 2009, it asked drug maker Takeda Pharmaceuticals to look at the heart risks associated with their gout drug. Uloric, generically known as febuxostat, was compared with allopurinol, another drug to treat gout.

The FDA notes in its 2017 safety communication that once they “receive the final results from the manufacturer, [they] will conduct a comprehensive review and will update the public with any new information.”

What is Gout?

Gout is a condition that occurs when too much uric acid is present in the body and crystallizes in the joints. This results in pain and inflammation for the patient. Those who experience gout may have sudden bouts of severe pain, swelling, and redness in the joints.

Gout can occur when the body has high levels of purines. When purines are broken down by the body, the process produces uric acid. High levels of uric acid in the body can lead to gout in a patient. Purines are chemicals that are found in meats and seafood.

Uloric Heart Related Deaths

The study that the FDA looked at regarding Uloric heart-related deaths when compared to those who used allopurinol (Zyloprim and Aloprim) showed an increase in Uloric heart-related deaths as well as an increase in deaths from other causes as well.

The Uloric heart related deaths study looked at 6,000 patients who either took Uloric or allopurinol. Not only did the study show an increase in Uloric heart related deaths, but it also showed the presence of other alarming Uloric side effects including non-deadly heart attack, non-deadly stroke, and cardiac ischemia requiring urgent surgery.

Cardiac ischemia is when there is not enough blood flowing to the heart.

When Uloric was approved in 2009, the label stated that there was a possibility of an increase in heart complications and stroke. This led the FDA to require drug maker Takeda to provide additional clinical studies.

In its Uloric heart related deaths communication, the FDA said, “Healthcare 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.”

If you have suffered from gout symptoms and have taken Uloric to minimize the condition, you may be at risk for Uloric heart related complications. It may benefit you to discuss your health concerns with your physician as well as discussing your legal options with an experienced attorney. While legal compensation cannot bring a loved one back to life, it can hold drug makers accountable for potentially dangerous drugs.