Uloric adverse reactions may include dangerous heart events like myocardial infarction or heart attack. These events may even result in the death of the patient.

Uloric and allopurinol are the two of the most common treatments for gout, a painful form of arthritis that typically—although not exclusively—tends to attack the joint of the big toe.

According to the National Law Review (NLR), Uloric was approved by the U.S. Food and Drug Administration (FDA) in 2009. This approval came on certain conditions due to Uloric adverse reactions that showed up during clinical safety trials.

Uloric—known generically as febuxostat—revealed a statistically significant rate of heart-related problems during the pre-approval trials that the FDA felt warranted follow-up.

The drug was initially approved, but the manufacturer was required by the FDA to investigate these Uloric adverse reactions further by conducting post-approval studies focused on cardiovascular health.

The pre-approval clinical trials revealed enough incidents of heart attack, strokes, and death via cardiac failure that the FDA required a warning to be added to the box.

Post-Approval Studies and FDA Communications

The follow-up clinical safety trial that was requested of Takeda Pharmaceuticals enrolled 6,000 gout patients divided equally between those taking Uloric and those taking allopurinol. The study supported the previous data indicating Uloric adverse reactions affecting the heart.

On Nov. 15, 2017, the FDA decided to release a safety communication indicating that there was an increase risk of heart-related death and death from all causes while ingesting the drug.

After extensive review of the study-related material, the FDA required Takeda to upgrade the warning posted on the drug packaging to a black box warning which took place on Feb. 21, 2019, according to the NLR article.

Furthermore, the FDA decided to limit the use of Uloric to those gout patients who had not found Allopurinol effective or who had had allergic reactions to that alternative.

What is Gout?

According to Medical News Today and the Centers for Disease Control, gout is a common type of arthritis which, between 2007 and 2008, affected 8.3 million Americans — disproportionately men. Women can also suffer from gout, but are much more likely to develop it after menopause if they contract it at all.

Gout is caused by excess uric acid in the bloodstream, however, not everyone that has hyperuricemia develops gout. Symptoms are episodic in nature and often come on in the middle of the night, causing excruciating pain in the affected joint or joints.

Symptoms usually abate 2 to 14 days after they begin. The pain can be controlled with non-steroidal anti-inflammatory drugs (NSAIDs), but the most effective treatment are drugs and diet to lower blood levels of uric acid.

Gout and Heart Disease

According to the Cleveland Heart Lab, by its very nature, gout is likely to increase the risk of heart disease. The high uric acid in the blood is deposited in the form of crystals in affected joints which spurs the body to inflame the area.

This is the same type of process which leads to blood clots and heart attacks. This being said, the newest Uloric clinic trial found increased risk over and above the baseline of the disease itself by strictly enrolling gout patients and dividing their treatment equally between the two choices.