Lawsuits Claim Uloric Exposes Users to Increased Risk of Heart Attack, Stroke and Death

Personal injury and wrongful death lawsuits are being filed against the companies that designed, manufactured, marketed, sold and distributed Uloric, by patients who were prescribed the gout treatment and subsequently suffered a heart attack, stroke or another serious medical problem, and by and family members who lost a loved one to a fatal cardiovascular injury or another life-threatening event allegedly caused by Uloric. If you or someone you love suffered a heart attack, stroke or another potentially life-threatening side effect during or after Uloric treatment, contact Consumer Safety Watch as soon as possible to find out if you meet the criteria for a Uloric lawsuit. The FDA has warned that Uloric use is associated with a higher risk of heart-related death and death from all causes, so don’t wait to call.

What is Uloric?

Uloric (febuxostat) is a xanthine oxidase (XO) inhibitor indicated for the chronic management of gout, a type of arthritis caused by excess uric acid in the bloodstream. Symptoms of gout include severe pain, redness and tenderness in affected joints, occurring when too much uric acid crystallizes and deposits in the joints. Patients experiencing chronic gout may reduce their alcohol intake and modify their diet and exercise routine in order to minimize the frequency of attacks. Additionally, patients may be prescribed medications like Uloric to reduce the amount of uric acid in the blood, which can help minimize the symptoms of the condition. However, a growing body of evidence has emerged in recent years establishing a link between Uloric and severe, potentially life-threatening cardiovascular problems in users.

Uloric Injury Lawsuits Filed Against Takeda Pharmaceuticals

For more than a decade, Takeda Pharmaceuticals has marketed its blockbuster gout medication as safe and effective for the chronic management of uric acid buildup (hyperuricemia) in patients with gout. A growing number of Uloric injury lawsuits filed in courts across the country allege that the drug maker sold the gout medication without providing adequate warnings about the possibility of severe Uloric side effects. Among the side effects allegedly linked to Uloric use are:

  • Heart attack
  • Stroke
  • Cardiovascular-related death
  • Death from all causes
  • Angina
  • Deep vein thrombosis
  • Pulmonary embolism
  • Kidney damage
  • Liver damage

One recent Uloric lawsuit was filed by a Texas woman on behalf of the estate of a family member who passed away in October 2017. According to the complaint, the decedent was prescribed Uloric in 2016 to treat her gout condition. After taking the drug for less than one year, the decedent suffered a heart attack that ultimately led to her death. The plaintiff, Vicky Finley, filed the lawsuit individually and on behalf of the Estate of Mary Finley, and alleges in the complaint that Takeda Pharmaceuticals concealed its knowledge of alleged Uloric defects and failed to provide users with adequate warnings about the potential risks of the gout treatment. “Rather than doing adequate testing to determine the cause of [users’] injuries or rule out Uloric’s design as the cause of the injuries,” the lawsuit states, “Defendants continued to market Uloric as a safer and more effective prescriptive drug as compared to other available alternative treatment[s].”

Clinical Trial Shows Increased Risk of Death with Uloric

When the FDA approved Uloric in 2009, the agency required a warning to be placed on the drug label notifying patients and doctors about the possible increased risk of cardiovascular events associated with Uloric treatment. The FDA also required Takeda Pharmaceuticals to conduct a post-marketing clinical trial to determine whether Uloric treatment was associated with any cardiovascular events in users. The results of the clinical trial, which was completed in July 2017, showed that while the overall rates of cardiovascular events were similar in patients taking Uloric and in those taking another gout medication called allopurinol, the risk of death from cardiovascular events and other causes was higher in patients taking Uloric than in patients taking allopurinol.

Uloric Black Box Warning for Increased Risk of Death

In February 2019, nearly two years after the clinical trial was completed, the FDA finally issued a black box warning for Uloric, notifying users about the increased risk of death associated with the gout medication. “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,” the FDA stated in a drug safety announcement. Based on these findings, the FDA updated the Uloric prescribing information to require a Boxed Warning, the agency’s most prominent drug warning, and a new patient Medication Guide. The FDA also limited the approved use of Uloric to certain patients for whom allopurinol treatment is ineffective or inappropriate. If you were prescribed the gout drug Uloric and subsequently suffered a heart attack or another serious side effect, contact us today to learn about your legal options.