Texas Personal Injury Law Blog

Uloric Lawsuits Allege Failure to Warn of Increases Risk of Death & Side-Effects

Several Uloric lawsuits have been filed alleging that the maker, Takeda Pharmaceuticals, failed to warn consumers of know risks of serious deadly side-effects affecting the heart, kidneys, liver, bone marrow and other important parts of the body.  The Uloric lawsuits began after Helen Ge, a former safety consultant for Takeda Pharmaceuticals filed Whistleblower actions against the company alleging that they were aware of serious side-effects and withheld such information. You should consult a Uloric lawyer if you took the medication and suffered any of the following conditions:

  • Heart Attacks
  • Stroke
  • Liver Failure
  • Kidney Damage
  • Rhabdomyolysis
  • Immune System Disorders
  • Urinary Issues
  • Severe Bleeding
  • Bone Marrow Failure

Uloric Study Concludes Increased Risk of Death

Uloric (febuxostat)  is a drug intended for the treatment of gout in adults that was approved for use by the United States Federal Drug Administration (FDA) in 2009.  In 2018, a Uloric study was performed and published in the New England Journal of Medicine under the title: Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout.  That study concluded that the “treatment with Uloric resulted in overall rates of major cardiovascular events that were similar to those associated with Allopurinol treatment among patients with gout who had coexisting cardiovascular disease. However, cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group”.

As a result of the study, FDA has concluded that there is an increased risk of death for patients taking Uloric vs patients taking a similar gout treatment drug called allopurinol.  If you suffered serious medical complications and/or side-effects while using Uloric or you lost a loved one who was under treatment using Uloric, a Uloric lawyer may be able to help.

The FDA Issues Uloric Safety Announcement

On February 21, 2019, the FDA issued the following safety warning:

“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 Box Safety Warning Required

In addition to making the above announcement, the FDA has announced that they will require Takeda Pharmaceuticals to post a Safety Warning on the box to help ensure patients are aware of the above risks before taking Uloric as well as a newly revamped medication guide for patients.  Further, the FDA is restricting approval of the drug’s use so that only patients who have experienced severe side effects while taking allopurinol or cannot be effectively treated with allopurinol.

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Paul Cannon

Paul Cannon has practiced personal injury trial law since 1995. He is Board Certified in Personal Injury Trial Law (2005). He has earned recognition as a Super Lawyer by Thompson Reuters in 2017 & 2018, and as a Top 100 Trial Lawyer by the National Trial Lawyers Association in 2017. He is a Shareholder, trial lawyer and online marketing manager at Simmons and Fletcher, P.C. His legal writings have been published by the Texas Bar Journal, Business.com, Lawyer.com HG Legal Resources, Lawfirms.com, and others. He has been asked to give education talks and media interviews on dog bite law.