Uloric (febuxostat), a Gout drug by Japan’s Takeda Pharmaceuticals, was marketed as an alternative to Zyloprim (allopurinol), a generic drug that had been on the market for many decades that had a stellar reputation for being safe, effective in the treatment of gout but was also inexpensive. Despite safety concerns and red flags, Takeda brought Uloric to market and influenced doctors to prescribe it based on what turned out to be false or misleading information causing many needless injuries and deaths in the process so that they could increase their profits.
The U.S. Food and Drug Administration (FDA) has found that there is an increased risk of death from adverse cardiovascular events such as heart attack, stroke and angina, and has thus required a “Boxed Warning” and a new patient Medication Guide explaining these risks to patients and doctors.
In 2012, Uloric maker Takeda Pharmaceuticals was hit with a whistleblower lawsuit filed by Dr. Helen Ge, a former safety consultant for the company, who claimed that the drug maker deliberately withheld from the public information about Uloric and potentially serious side effects, including kidney damage, liver problems and bone marrow failure, among other problems.
Ge also alleged in her whistleblower lawsuit that Takeda defrauded Medicare and Medicaid; failed to warn the public that Uloric could interact with other medications, possibly resulting in dangerous side effects; and altered documents sent to the FDA to make it seem as though the cardiac side effects of Uloric were less severe than they actually were, which may have resulted in the death of some patients taking the gout medication.
Takeda’s Uloric drug is also the subject of a growing number of product liability lawsuits filed on behalf of individuals across the country who allegedly suffered serious injuries as a result of taking the gout medication, such as liver damage, rhabdomyolysis, kidney failure, heart attack, stroke, death and more.
Uloric lawsuits allege that Takeda Pharmaceuticals:
• Manufactured a defective medication
• Knew or should have known about the potential for Uloric to cause serious side effects in users
• Knew that Uloric treatment could cause dangerous drug interactions
• Failed to issue adequate warnings about these risks
• Defrauded Medicare and Medicaid by overcharging for the gout medication
• Downplayed the risk of cardiac side effects from Uloric by altering documents sent to the FDA
“The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.”
Uloric (febuxostat) is a prescription medication manufactured by Takeda Pharmaceuticals and first approved by the FDA in 2009 to treat gout, a common type of inflammatory arthritis caused by excess levels of a naturally occurring substance in the body called uric acid. When uric acid builds up in the bloodstream, it can cause gout, a chronic condition characterized by intense pain, stiffness and swelling in a joint. These symptoms are caused by the formation of uric acid crystals in the affected joints and the body’s response to them, and they can reoccur over time, slowly harming tissues in the affected area. Gout is sometimes treated with medications like Uloric, a xanthine oxidase inhibitor designed to lower uric acid levels in the blood of patients with gout. Gout has been linked to an increased incidence of metabolic and cardiovascular disease and the FDA reports that “the number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.” However, the FDA has concluded that patients taking Uloric have an increased risk of death compared to patients taking other gout medications.
Compensation from a Uloric lawsuit could help cover the cost of:
• Past and future medical expenses
• Pain and suffering
• Funeral expenses
• Medical expenses prior to death
• Loss of future earning potential
• Loss of economic support
• Lost wages
• Emotional distress
• Loss of companionship
• Wrongful death
Based on an in-depth review of the results of a Uloric clinical trial, the FDA issued a “Boxed Warning” to the drug label in February 2019, indicating that “there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol.” According to the FDA, Uloric treatment may increase the risk of heart-related death and death from all causes. As a result of these findings, the FDA took action to limit the approved use of Uloric to certain patients for whom allopurinol treatment is ineffective or causes severe side effects. A “Boxed Warning” is the FDA’s most serious warning, reserved for instances where one or more of the following apply:
• If an adverse event is so serious (death or a permanently disabling reaction) in proportion to the potential benefit from the drug that it is essential to consider when weighing the risks and benefits of the drug;
• If a serious adverse reaction can be prevented, reduced in frequency, or made less severe by following certain guidelines, such as patient selection, careful monitoring, or taking into account other medication that the person might be taking; and/or
• If there are mandatory restrictions for prescribing the drug. Some medication may only be administered in certain settings (supervised or inpatient) or may require the doctor to complete extra training in order to prescribe.
The FDA’s 2019 Uloric warning updated a previous drug safety communication published in 2017, which revealed an increase in heart-related deaths associated with Uloric treatment. According to the results of a safety study the FDA required Takeda to perform when Uloric was first approved in 2009, Uloric treatment was associated with an increased risk of “heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.”
