Uloric, a commonly-prescribed gout medication, has been associated with cardiac ischemia, non-fatal heart attacks and stroke and patient deaths. A qui tam (whistleblower) lawsuit filed in 2012 by a former employee of the manufacturer, Takeda Pharmaceuticals, alleged that the company was aware of these risks and others  – but engaged in a campaign to minimize and even conceal information about the dangers associated with the product. The whistleblower claimed this alleged concealment also resulted in fraud against federal health care programs when patients were switched to the new drug at considerable expense.

About Uloric

The medication that has been linked to cardiac ischemia (reduced blood flow to the heart) and numerous other side effects received FDA approval in 2009. Uloric (febuxostat) is indicated for the treatment of gout, or “gouty arthritis,” which is due to high levels of uric acid in the blood. Symptoms include sudden, painful inflammation and swelling in the joints.

Early clinical trials indicated an elevated risk of cardiac ischemia, myocardial infarction and stroke. Nonetheless, FDA approval was granted on the conditions that a clear warning would be included on the package label – and that Takeda would conduct post-marketing studies. However, according to one former Takeda employee, there was more information that the company failed to disclose.

What Was the Drugmaker Hiding?

In 2012, Dr. Helen Ge, a former Takeda safety consultant, filed a qui tam lawsuit alleging that the company falsified documents that were submitted to the FDA, making the known side effects seem less severe than they actually were.

She also claimed Takeda failed to disclose the serious danger of interactions with other commonly-prescribed medications such as warfarin (an anticoagulant), digoxin (a digitalis-based heart medication), azathioprine (an anti-rejection drug) and methadone (used to treat substance abuse). Several patients died allegedly as a result of this withholding of information.

There was more, according to Dr. Ge. Her lawsuit alleged that Takeda concealed information on links between Uloric and bone marrow disease, hemorrhaging and kidney failure. Based on this allegedly faulty and incomplete information, the federal Medicare and Medicaid programs switched patients to the new product – which cost fifty times as much as the former medication, allopurinol.

The FDA Updates its Findings

In November 2017, the FDA issued a safety announcement about the “increased risk of heart-related death with febuxostat (Uloric) compared to…allopurinol.” The original safety studies involved 6,000 gout patients who received either Uloric or allpurinol. While the preliminary results showed little difference in terms of risk from the respective medications, a later evaluation showed Uloric was associated with “an increased risk of heart-related deaths and death from all causes.”

A Cause of Action: Cardiac Ischemia, Heart Attack, Stroke and More

In the wake of Ge’s whistleblower lawsuit and the revelations that are coming out of it, law firms are reaching out to people who have suffered injuries from taking Uloric as well as surviving family members of those who have died as a result of taking the medication. These individuals may qualify to sue for medical expenses, loss of income, pain and suffering and wrongful death.