Uloric heart side effects can lead to a possible increased risk of death from heart-related causes.

Chicago-based Takeda makes Uloric (febuxostat), the first new gout medication approved in 40 years when the FDA approved the drug in 2009. Uloric emerged as the first competitor to alternative medication allopurinol, sold under the brand names Zyloprim and Aloprim.

Gout is an inflammatory arthritis that appears when uric acid in the blood becomes too high. The excess acid crystallizes in the joints, producing pain, warmth, redness, and swelling. Nearly 8 million Americans suffer from gout, which is more common among people with diabetes, chronic kidney disease, high blood pressure, heart disease or obesity.

A whistleblower lawsuit filed by a former employee of Takeda Pharmaceuticals, maker of Uloric, alleges the drug maker hid the drug’s dangerous side effects. Former Takeda safety consultant Helen Ge said the company failed to report potentially deadly Uloric heart side effects that could occur when the drug was used a combination with other drugs such as digoxin, Imuran, methadone, and warfarin.

Ge found that Uloric contains the same metabolizing enzyme found in methadone. The combination of the two drugs allowed the enzyme to remain active within the body for a longer period of time, which allegedly led to a fatal overdose in one patient. Other adverse side effects of Uloric when combined with other drugs include the possibilities of bone marrow failure, extreme bleeding, and kidney failure, according to Ge. She also alleged that Takeda manipulated adverse event reports to falsify the impression that Uloric was safer than it really is.

Takeda Accused of Hiding Uloric Heart Side Effects

A Uloric side effects clinical study found that “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.”

Because Takeda allegedly hid Uloric heart side effects when marketing the drug, the company is accused of defrauding Medicare and Medicaid. Few would have paid the $5 per day cost for the medication (allopurinol is only 10 cents a day) had they known that Uloric heart side effects and adverse drug interactions would have put them at risk.

According to Uloric’s current website information, the most commons side effects are nausea, liver problems, gout flares, joint pain and a rash. Safety information says, “A small number of heart attacks, strokes, and heart-related deaths were seen in clinical studies.”

A post-market clinical trial of 6,000-plus patients recently concluded and once the FDA reviews those results of Uloric heart side effects, the findings will be released to the public.