Uloric Whistleblower Lawsuits Allege the Manufacturer Withheld Dangerous Side Effect Information

First introduced onto the market in February 2009, Uloric (febuxostat), manufactured by Takeda Pharmaceuticals, was the first medication formulated to treat gout in more than four decades. However, not long after its introduction, many individuals have come forward with reports of serious side effects from using the drug.

Uloric and the treatment of gout

Uloric is a prescription medication given to patients suffering from gout, a form of arthritis that develops when uric acid crystals accumulate in the joints. The result is inflammation. Uloric works to reduce the level of this acid and thus reduce the inflammation. The condition is more commonly found in men than in women, but affects millions of people each year.

The symptoms of gout include unexpected attacks of redness and pain and swelling in one or more joints. Risk factors for the onset of gout include:

• Obesity
• Alcohol consumption
• Diet rich in seafood and meat
• Having a family history of gout
• Diabetes
• Recent surgery
• Certain medications

As a new treatment with great promise to relieve the symptoms and pain of gout sufferers, Uloric seems to have fallen short of expectations. Takeda failed to warn the public concerning serious and even life-threatening side effects which have been experienced by users of the dangerous drug.

Legal action against the manufacturer

Dr. Helen Ge, a former safety consultant for Takeda issued a whistleblower lawsuit against the manufacturer. The claim made by Dr. Ge is that the company did not reveal available risk information about Uloric and its possible serious side effects – these include liver problems, kidney damage, and bone marrow failure. The claim also asserts that the company failed to inform the public that the drug could interact with other medications producing negative results.

The lawsuit also claims that the manufacturer made the cardiac side effects of Uloric less severe than reality by modifying and altering documents they sent to the FDA. Allegedly, the failure to provide this information resulted in the death of some patients taking the drug.

Additionally, the lawsuit contends that Takeda’s actions defrauded Medicare and Medicaid due to the fact that febuxostat costs 5 dollars per day, while allopurinol, an alternative treatment for gout, costs only 10 cents per day.

Cardiac deaths due to Uloric use

The FDA published a safety communication concerning Uloric in November 2017 after a clinical trial revealed an increase in heart related deaths associated with the use of the drug. The study, which evaluated 6000 individuals, found that those using Uloric had an elevated risk of inadequate blood supply, nonfatal stroke, nonfatal heart attack, and heart related death. Urgent surgery was often required as a result of these conditions.

Kidney failure and Uloric use

Prior to September 2017, there were no dosing recommendations on Uloric’s labeling for patients suffering from serious renal impairment. However, with more reports of injuries coming forward, the label has now been changed to a recommended limited dose of 40 mg per day for those with severe renal impairment. The dosing recommendations for patients suffering from mild to moderate renal impairment are unchanged.

If you or someone you love has experienced health complications, including possible cardiovascular issues, while taking Uloric, you may have legal recourse to recover damages. At McGowan, Hood, Felder & Phillips, LLC, our focus is on helping our clients like you achieve the financial relief they need in the face of hardship and losses they have endured due to another party’s medical negligence or malpractice.

To arrange a free consultation about your case, call our law office today at 803-327-7800 or send us a request through our contact form.