The FDA says that Uloric heart side effects could be a serious risk for patients taking the gout medication.

Uloric (febuxostat) is made by Takeda Pharmaceuticals. Clinical trials indicated patients taking Uloroic had a higher rate of heart attacks, strokes and cardiac deaths than patients who were taking an alternative gout medication known as allopurinol, sold under the brand names Zyloprim and Aloprim.

The FDA  recently released a statement about the clinical study noting, “The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.

“The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”

Another clinical trial of more than 6,000 patients recently ended, and the FDA plans to review those results and release the findings to the public.

Uloric Heart Side Effects Among Allegedly Hidden Adverse Effects

Gout is a type of inflammatory arthritis caused by a high level of uric acid in the blood. The increased acid crystallizes in the joints, where it causes severe pain. Gout can appear to be an infection because of the tenderness, redness, warmth, and swelling associated with the condition.

Approximately 6 million men and 2 million women in the United States are affected by gout. Patients who suffer from high blood pressure, diabetes, chronic kidney disease, cardiovascular disease, or obesity are at higher risk for gout.

A former Takeda safety consultant filed a whistleblower lawsuit alleging the company withheld information about significant adverse side effects and failed to disclose dangerous drug interactions from the FDA, doctors, and patients. In addition to Uloric heart side effects, the medication allegedly has been linked to bone marrow failure, kidney failure, severe bleeding, liver failure, psychotic behavior, and severe rashes, including Stevens-Johnson syndrome.

The whistleblower lawsuit also alleges that Takeda knew but failed to inform others that Uloric could cause possibly fatal side effects when used in combination with other medications, including methadone, Imuran, digoxin, and warfarin.

Takeda allegedly hid Uloric heart side effects and other adverse reactions or minimized the risks in documents provided to the FDA. These misrepresentations and falsehoods allegedly enabled Uloric to become the first new gout medication to be FDA-approved in more than 40 years when it went on the market in 2009. Takeda also stands accused of defrauding Medicare and Medicaid because Uloric costs $5 a day compared to allopurinol’s cost of 10 cents per day, according to the whistleblower lawsuit.

Patients who have taken Uloric and suffered adverse side effects may be able to file a lawsuit against the pharmaceutical manufacturer. Successful plaintiffs may receive compensation for past and future medical bills as well as compensation for the plaintiff’s pain and suffering.  A legal professional can help potential plaintiffs determine if filing a lawsuit is right for them.