The U.S. Food and Drug Administration (FDA) is requiring a new warning to be added regarding the side effects of Uloric medication. The federal agency warns that febuxostat drugs like Uloric have been linked with an increased risk of cardiovascular death.

According to the FDA update, patients treated with febuxostat, when compared with those taking the gout drug allopurinol, may face an increased risk of cardiovascular (CV) death and all-cause mortality. The safety announcement was made when the findings of a major clinical trial conducted by Takeda Pharmaceuticals were released.

The clinical trial included around 6,000 patients with gout and was a requirement of the initial FDA approval of Uloric back in 2009. Initial data shows that the use of Uloric increases the risk of death from cardiovascular problems.

“This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric,” read an FDA statement posted on their website.

Because of these risks, FDA officials have limited its approval for use of Uloric only to patients for whom treatment with allopurinol is ineffective or causes severe side effects.

Basics of Uloric

Uloric (also known by its generic name, febuxostat) is a gout medication first approved by the FDA in 2009. Uloric is manufactured by Takeda Pharmaceuticals.

Gout is a form of arthritis that occurs when uric acid builds up in the body, causing a range of issues including redness, swelling, and pain in joints. In order to treat these issues, Uloric works to lower uric acid levels in the blood.

Unfortunately, patients taking Uloric may not have been given adequate warning about the side effects associated with the popular gout medication, placing them at serious risk.

Side effects of Uloric medication include an increased cardiovascular risk, which can lead to cardiac arrest or even death. The clinical trial found that the use of Uloric was associated with an increased risk of heart-related death when compared with the use of another popular gout medication, allopurinol.

Uloric heart-related risks include stroke, cardiac ischemia requiring emergency surgery, non-deadly heart attacks, and fatal heart attacks.

If you are being treated with a febuxostat medication like Uloric and experience any of the following symptoms, you should seek immediate medical attention: chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, difficulty talking, or sudden severe headache.

Filing a Uloric Lawsuit

If you or someone you love has suffered from these or other side effects of Uloric medication, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot undo the pain and suffering caused by these sometimes serious side effects, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.