The Gout medicine Uloric has been linked to a possible increased risk of death from heart-related causes, according to a warning issued by the FDA.

A study released by drug maker Takeda Pharmaceuticals reportedly shows Uloric (febuxostat) patients have a higher risk of cardiac-related deaths and death from all causes compared to patients taking alternative gout medication allopurinol, sold as brand names Zyloprim and Aloprim.

In response, the FDA released two Drug Safety Communications in November 2017. The first alert said the FDA will evaluate gout medicine Uloric and the association of an increased risk of heart-related deaths. The second notice indicated the FDA will evaluate deaths from all causes, as well as heart-related deaths related to Uloric.

The FDA approved Uloric in 2009, and it was the first new gout medication approved in 40 years. Initial clinical trials reportedly indicated an increased risk of heart attacks, strokes, and heart-related deaths, all of which are mentioned on Uloric’s warning label. These findings led the FDA to ask Takeda to conduct another study even after the gout medicine Uloric went on the market.

According to Uloric’s website, the most common side effect is that gout can flare up when a patient first starts taking the medication. “[T]his may be due to crystals beginning to dissolve in your joints as your uric acid level goes down,” the website states.

Patients are advised to ask their doctor about taking additional gout management medications to prevent or reduce flares upon initial treatment. Other common side effects are liver problems, nausea, joint pain, and rash. Some serious side effects may develop with gout medicine Uloric.

In rare cases, a rash can develop into Stevens-Johnson Syndrome, a possibly life-threatening allergic reaction.

Takeda Allegedly Hid Adverse Effects of Gout Medicine Uloric

One of Takeda’s own former safety consultants filed a whistleblower lawsuit because the company allegedly hid adverse side effects and known harmful drug interactions from doctors, patients, and the FDA.

The whistleblower lawsuit says that Takeda knew that gout medicine Uloric could induce heart problems, bone marrow failure, severe bleeding, kidney failure, liver failure, psychotic behavior, and severe rashes. Takeda allegedly hid these findings in order to rush the drug to the market.

Gout medicine Uloric can have fatal interactions with other medications such as methadone, warfarin, Imuran, and digoxin, but Takeda took no steps to share the possibly dangerous indications.

Approximately 8 million U.S. citizens experience gout, which is a type of inflammatory arthritis. High levels of uric acid in the blood crystallize in the joints, causing severe pain. Gout mimics infection because of the warmth, tenderness, redness, and swelling experienced by the affected joint.

Patients who already fight high blood pressure, chronic kidney disease, diabetes, cardiovascular disease or obesity are more apt to develop gout attacks.

Gout medicine Uloric has not been taken off the market, but the FDA warns healthcare professionals to “consider this safety information when deciding whether to prescribe or continue patients on febuxostat.”