Recent research suggests an increased risk of Uloric cardiac related death, news that’s concerning to both gout patients and the medical community. According to the U.S. Food and Drug Administration (FDA), incidents of Uloric cardiac related death have been reported in patients taking the gout medication.

In February 2019, the FDA updated the mediction’s prescribing information to include a boxed warning  –the agency’s most prominent warning — cautioning consumers of the increased risk of cardiac related death. The boxed warning came 15 months after the initial results of a large safety trial, funded by Takeda Pharmaceuticals, that showed an increased risk of cardiac related death for patients taking Uloric when compared to other gout medications.

The FDA approved Uloric in 2009 as a treatment medication for a type of inflammatory arthritis called gout. Gout is caused by a buildup of uric acid in the joints. according to the Mayo Clinic. Uric acid is produced when the body breaks down purines (naturally occuring substances in the body) and is filtered  through the kidneys.

When uric acid builds up in the joints it can cause tissue inflammation, redness, and limited range of motion, making life very difficult for patients. Uloric works by reducing the amount of uric acid in the blood, which then reduces the inflammation.

It’s important to note that Uloric was marketed as a safe alternative to allopurinol, an older gout drug associated with an increased risk of kidney problems and allergic reactions. However, the recent safety trials show that Uloric patients may come with its own set of caveats: an increased risk of cardiac death.

Overview of Uloric Study

The FDA ordered Takeda Pharmaceuticals to conduct the study after early clinical trials showed an increased risk of Uloric cardiac related death, including incidents of heart attacks and strokes. While these complications are included on the warning label, the FDA ordered Takeda to conduct the post market study to further expose any potential dangers.

According to the results of the study, patients faced in an increased risk of cardiovascular death, non-fatal heart attack or stroke, and cardiac ischemia. Ischemia occurs when the heart experiences a decrease in blood supply, and requires urgent surgery to prevent further complications.

Furthermore, patients experienced an overall 34 percent increased risk of Uloric cardiac related death and a 22 percent increased risk of death overall, compared to allopurinol.

The study also found that mortality rates among Uloric and allopurinol patients with a history of chronic kidney disease climbed, and patients who discontinued Uloric after the study faced a decreased risk of death.

FDA Issues Two Uloric Safety Warnings

The results of the study spurred the FDA to issue two safety warnings on Nov. 15, 2017. The first warning stated the agency would evaluate the potential increased risk of Uloric cardiac related death, and the second warning said the FDA would be evaluating all patient deaths, including cardiac-related deaths allegedly linked with Uloric use.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat,” according to the FDA.

“[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.”

What Are the Signs of a Heart Attack?

Heart attacks can affect anyone, but patients taking certain medications like Uloric might not be aware of the increased risk of a fatality from the medication. This makes it even more important for Uloric patients to be mindful of the signs of a heart attack or other heart related issues so that he or she can seek medical attention immediately.

Most people who experience an emergency heart issue fail to get help because they don’t realize it’s a heart attack. Sometimes the symptoms vary between patients or even with one patient who has had multiple attacks may experience different symptoms with each one.

Any delay in getting medical help can increase the damage to the heart muscle. Anyone who thinks they might be suffering from a heart issue should call 911 immediately just in case. A heart attack may begin with mild pressure or pain in the chest that may not be obvious that it signals the beginning of a serious cardiac event.

At the hospital, doctors try to open the blocked artery no later than 90 minutes after the onset of symptoms. The heart might require blood flow with the help of a balloon.

Warning signs of a heart attack include fullness, stabbing pain, squeezing, or uncomfortable pressure, according to sercondscount.org. Other symptoms can include shortness of breath, discomfort throughout the upper body, changes in heart rhythm, dizziness, or breaking out in a cold sweat.  These could also be signs of Uloric cardiac related death.