This Drug is Linked to an Increased Risk of Death in Patients. So Why is it Still Being Prescribed for a Non-Life-Threatening Condition?

Gout, a common type of arthritis caused by excess uric acid in the bloodstream, is a painful and potentially debilitating condition affecting more than eight million adults in the United States. If you have been diagnosed with gout, you know that the chronic joint pain characteristic of the disease can be difficult to control. And if you found out you could manage your gout symptoms by taking a once-daily prescription pill, you might jump at the chance. But what if you were told that the tradeoff for taking this pill to treat gout – a non-life-threatening condition – was an increased risk of death? Would you take that risk? This is the question at the center of the dispute surrounding Uloric (febuxostat), a prescription gout medication that has been linked to an increased risk of heart-related death and death from all causes.

Uloric Aggressively Marketed as Safe and Effective

When drug manufacturing companies fail to disclose the potential side effects of the medications they aggressively market to consumers, they rob consumers of the right to make informed decisions about these medications, taking into account the benefits and risks. Uloric, for example, was introduced by Takeda Pharmaceuticals in 2009 and quickly became a blockbuster treatment for gout, bringing in $1.9 billion in sales for Takeda between 2012 and 2017. During this time, Uloric was touted as a safe and effective gout medication, indicated for the chronic management of hyperuricemia in patients with gout. It became the go-to treatment for gout sufferers, ahead of an older gout drug called allopurinol, and was prescribed to millions of people dealing with gout symptoms like pain, swelling, tenderness, and redness in one or more joints.

In 2018 is when things started to go wrong for Uloric and Takeda. That June, the nonprofit consumer advocacy organization, Public Citizen, petitioned the FDA to immediately remove Uloric from the market in light of “overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit.” The petition revealed that there were concerns about the safety of Uloric before the gout medication was even approved by the FDA in 2009, and stated that the FDA should have required Takeda to conduct a safety clinical trial to assess the possible risks of serious adverse cardiovascular outcomes, including heart attack, stroke, and heart-related death, before the drug was approved, not after. The petition went on to say that allowing Uloric to remain on the market in the U.S. ensures “further preventable harm” to patients.

FDA Adds Black Box Warning to Uloric Label

The year after Public Citizen submitted its petition to the FDA, after Uloric had already been on the market for an entire decade, the FDA finally took action, reporting in a drug safety communication that Uloric is associated with an increased risk of death compared to allopurinol. In response to these findings, which were based on the agency’s “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,” the FDA added a boxed warning – its most serious warning for pharmaceutical drugs – to the Uloric label. The agency also restricted the use of Uloric to patients who are unable to take allopurinol due to severe side effects or to those for whom allopurinol treatment is not effective. Unfortunately, the agency stopped short of issuing a Uloric recall, and the prescription gout medication is still available for consumer use in the U.S.

Uloric Lawsuits Accuse Takeda of Failure to Warn

Now that the public has finally been notified about the potential for Uloric to cause serious cardiovascular problems or death in users, a growing number of Uloric lawsuits are being pursued against Takeda Pharmaceuticals by former Uloric users and the family members of those who died from heart attacks, strokes, and other health problems. Each Uloric lawsuit involves similar claims that patients could have avoided these serious drug complications had they been properly warned by Takeda or the FDA. If you believe you may be eligible for a Uloric injury claim, contact us as soon as possible to find out how we can assist you with your claim. A lawsuit may help you recover compensation for your medical expenses, pain and suffering, and other damages, so don’t wait to call.