Studies have indicated that the gout medication Uloric may be linked to serious cardiac side effects, including a Uloric heart attack or even heart-related death.

If you or someone you love has taken Uloric and later suffered from side effects like a Uloric heart attack, you may be able to pursue compensation for your pain and suffering.

Background of Uloric

Uloric (also known as febuxostat) is a gout medication manufactured by Takeda Pharmaceuticals and approved by the FDA in 2009.

Uloric treats gout by reducing the amount of uric acid in the body. Gout is a form of arthritis caused by a buildup of uric acid, which leads to redness, swelling, and severe joint pain in one or more joints. It most often affects the metatarsal joint of the great toe, although other joints are not immune from its effects.

What Causes High Uric Acid Levels?

According to the Mayo Clinic, a build-up of uric acid in the body is often related to the kidneys’ inability to ‘keep up’ with the elimination of this element present in a purine-rich diet with lots of organ, game, and red meats and seafood. It is also associated with a more than average amount of alcohol consumption.

There are genetic tendencies as well as pre-existing conditions such as hypothyroidism, psoriasis, and renal system compromise which can contribute to its development.

Poor health habits such as maintaining an excessive amount of extra body weight and failing to exercise are also factors that may bring a condition of gout to the forefront of a patient’s health concerns.

Recent Uloric FDA Actions

Any medication will bring with it certain risks, and Uloric is no exception. The drug has reportedly been linked with far more serious side effects than patients may have been led to expect.

The Food and Drug Administration (FDA) issued a warning in November to patients and the medical community over serious risks associated with Uloric.

The warning was prompted by a mandated clinical study by the FDA upon the drug’s approval in 2009. Pre-approval clinical studies had already identified some increased cardiovascular risk with the drug and so follow-up with a larger group was necessary. The Uloric study took a look into Uloric and a competitive drug, comparing their relative risks.

The study, which included more than 6,000 gout patients, found that Uloric, when compared with allopurinol (also sold as Zyloprim and Aloprim), increased a patient’s risk of heart-related deaths, including deaths from a Uloric heart attack.

Other Uloric side effects linked with the gout drug include strokes, cardiac ischemia requiring emergency surgery, and non-deadly Uloric heart attack.

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

According to the Pharmacy Times, the FDA decided upon further review of the data to require a boxed warning to be put on the packaging for Uloric and to have the medication guide accompanying the drug updated accordingly.

The ‘black box’ warning is the strongest warning level the FDA issues. It is set off by bold text and a bold outline to draw attention to its contents.

The FDA has also decided with this latest action to curb the ability of a physician to prescribe the drug, except under certain circumstances.

First, the competitive drug Allopurinol or its equivalent must have proven to be ineffective with the patient in question. A second situation warranting the prescription of Uloric by the FDA is if the patient is allergic or experienced intolerable side effects with alternative treatments.

Takeda is not new to Uloric-related litigation. In 2012, a whistleblower lawsuit was filed by a former safety consultant who worked for Takeda, who alleged that the drug maker actively hid essential information about negative Uloric side effects from the government, by way of changing and falsifying documents sent to the FDA.

According to that Uloric lawsuit, Takeda defrauded Medicare and Medicaid by diverting patients who would take allopurinol for 10 cents per day to take Uloric instead, for $5 per day.

Filing a Lawsuit Over Uloric Side Effects

If you or someone you love has suffered from an Uloric heart attack or other side effects, you may be able to file an Uloric lawsuit.

While filing a lawsuit cannot take away the pain and suffering caused by Uloric side effects, or bring a loved one back to life after an Uloric heart attack, litigation may be able to help alleviate the financial burden caused by medical expenses, lost wages, and other damages.