Uloric is a medication prescribed for the management of excess uric acid in the blood (hyperuricemia) of adult patients with gout. The number of medications available to treat gout is limited and for nearly ten years after it was approved by the FDA, Uloric was considered the gold standard for the treatment of the condition. In 2019, however, federal regulators warned that Uloric exposes users to a higher risk of death than a rival gout medication called allopurinol and should not be used as a first-line treatment for patients experiencing symptoms of gout. Gout is a chronic disease that affects an estimated 8.3 million adults in the United States, many of whom have few alternative treatment options. As painful and irritating as gout may be though, it is important that gout sufferers understand the potential risks associated with taking Uloric to treat the condition, some of which include heart attack, stroke, kidney failure, and cardiovascular death.
Treating Gout with Uloric
Gout is a chronic form of arthritis that primarily affects the joints in the big toe where it connects to the foot, though it can also affect the joints in the ankles, knees, fingers, wrists, and elbows. Gout is caused by the buildup of a naturally occurring substance called uric acid in the bloodstream. The kidneys are responsible for flushing uric acid out of the body after it dissolves in the blood, but if the body produces too much uric acid or the kidneys excrete too little, the acid can accumulate in the bloodstream and may eventually settle in the joints and surrounding tissue in the form of sharp, needle-like crystals. These crystals are responsible for the sudden attacks of redness, swelling, pain, and inflammation in the joints that are characteristic of gout.
Uloric (febuxostat) is designed to treat gout by lowering the amount of uric acid in the blood. Uloric was approved by the FDA in 2009 and quickly became a popular treatment choice for gout sufferers. Today, Uloric is one of only a few medications available to those experiencing severe joint pain associated with gout. However, people who take Uloric to treat their gout symptoms may find themselves facing far more serious problems.
Side Effects Linked to Uloric
The potential for Uloric treatment to harm users has been evident for well over a decade. In fact, before giving Uloric the green light in 2009, the FDA had previously rejected the drug in 2005 and again in 2006, due to concerns about the possible cardiovascular risks associated with the gout drug. The following are some of the serious, potentially life-threatening side effects that have been linked to Uloric treatment:
- Heart attack
- Stroke
- Kidney failure
- Liver failure
- Serious skin reactions
- Cardiovascular death
Uloric Postmarket Safety Clinical Trial Results
When the FDA approved Uloric for the treatment of gout more than ten years ago, the agency included a warning in the drug prescribing information about the possibility of Uloric users suffering cardiovascular side effects. The agency also required Uloric maker Takeda Pharmaceuticals to conduct a clinical trial to assess the postmarket safety of the medication. The trial included more than 6,000 patients with gout taking either Uloric or another gout drug called allopurinol and the results of the trial showed that patients taking Uloric had an increased risk of heart-related death and death from all causes compared to those taking allopurinol.
FDA Adds “Black Box” Warning to Uloric Label
Based on the FDA’s review of the Uloric safety clinical trial data, the agency updated the drug label in February 2019, adding a “black box” warning about the increased risk of death associated with the gout medication. According to the FDA Drug Safety Communication, “there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol.” Rather than issue a Uloric recall, however, the agency allowed the drug to remain on the market, indicating that it should only be used in patients who are not treated effectively or cannot tolerate treatment with allopurinol.
Lawsuits Over Uloric Injuries, Patient Deaths
Gout is a common form of arthritis that can affect virtually anyone, though there are certain risk factors that can increase a person’s likelihood of developing gout, including diet, obesity, certain medical conditions, a family history of gout, recent surgery or trauma, and certain medications. For close to ten years, people diagnosed with gout relied on Uloric to lower the amount of uric acid in their blood and relieve their painful gout symptoms, and the drug was prescribed by doctors millions of times. However, since the FDA issued the Uloric black box warning in February 2019, people who took the popular gout medication and suffered serious cardiovascular events and the loved ones of those who died after taking Uloric have begun filing product liability lawsuits against Takeda Pharmaceuticals. These Uloric lawsuits allege that the drug maker failed to disclose the potentially life-threatening side effects of Uloric to consumers and healthcare providers.