Uloric Side Effects Pose Unreasonable Risk of Heart Attack, Stroke and Cardiovascular Death
Nearly a decade after Takeda Pharmaceuticals introduced Uloric, the drug maker has finally added stronger warnings about the risk that the controversial gout drug may cause heart attacks, strokes and wrongful death. However, if earlier warnings had been provided about the potential Uloric side effects, many individuals may have avoided serious and life-threatening injuries.
The lawyers at Saiontz & Kirk provide free Uloric lawsuit evaluations to help determine whether compensation may be available as a result of the drug maker’s failure to adequately research the gout medication before it was introduced, and apparent decision to place their desire for profits before consumer safety by placing false and misleading warnings on the drug.
Uloric Heart Risks Suspected For Years
The FDA first approved Uloric in 2009 for the treatment of gout, which is a painful form of arthritis that impacts millions of Americans.
Uloric was designed by Takeda Pharmaceuticals to lower the blood uric levels among adults diagnosed with gout, but it now appears that the drug maker knew or should have known that side effects may pose serious cardiovascular risks that are not associated with other, equally effective gout treatments.
Before Uloric was ever introduced, researchers from the University of Chicago raised questions about whether the expermental gout drug make increase the risk of death when compared to Zyloprim (allopurinol).
According to findings published in the New England Journal of Medicine in 2005, researchers found that 0.8% of patients treated with Uloric died, compared with none of the patients treated with allopurinol. However, it has become increasingly clear that Takeda ignored these safety signals about problems with Uloric.
Takeda Withheld Information About Side Effects of Uloric
Rather than conducting further research into the Uloric heart risks, Takeda Pharmaceuticals pushed ahead with marketing of the drug, which was approved with FDA requirements that the manufacturer conduct post-marketing clinical trials to compare the rates of cardiovascular events linked to Uloric and allopurinol.
While that research was yet to be completed, a former Takeda Pharmaceuticals employee filed a whistlebloder lawsuit that alleged the drug maker was withholding known information about the side effects of Uloric, including a risk of death when the gout drug was used with medications like digoxin, a heart medication, and the blood thinner warfarin.
The lawsuit also alleged that Takeda altered and falsified adverse event reports to hide potential side effects, which could include bone marrow failure, severe bleeding and kidney failure in order to make it appear more competitive against allopurinol.
After results of the post-marketing clinical trials were released, the FDA issued a drug safety communication in November 2017, about increased rates of:
- Heart Related Death
- Heart Attacks
- Unstable Angina (condition involving inadequate blood supply to the heart requiring intervention)
Although consumer advocacy groups like Public Citizen urged the FDA to require a Uloric recall, indicating that side effects outweigh any potential benefits, Takeda Pharmaceuticals continued to defend the safety of their drug during FDA advisory panel meetings earlier this year, and failed to add warnings for years after these troubling findings were released about the risk of heart problems.
Uloric Black Box Warning
In February 2019, the FDA finally announced that Takeda was being required to add a Uloric “Black Box” warning, which is the strongest caution that can be placed on a prescription medication. The Uloric label (PDF) now contains a prominently placed boxed warning that indicates:
WARNING: CARDIOVASCULAR DEATH
Gout patients with established cardiovascular (CV) disease treated with ULORIC had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.
Consider the risks and benefits of ULORIC when deciding to prescribe or continue patients on ULORIC. ULORIC should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
Uloric Lawyers Provide Free Case Evaluations
It appears that Takeda knew or should have known that side effects of their gout medication increased the risk of heart attacks, strokes and death for years, yet the pharmaceutical company chose to withhold these important warnings from consumers and doctors for nearly ten years. As a result, Takeda generated billions in profits, and many individuals throughout the U.S. have suffered serious and life-changing injuries.
The Uloric lawyers at Saiontz & Kirk, P.A. can help determine whether financial compensation may be available for individuals who suffered a:
- Heart Attack
- Pulmonary Embolism or Deep Vein Thrombosis
- Wrongful Death
All cases are handled by our law firm under a contingency fee agreement, which means that there are never any out-of-pocket costs associated with hiring an attorney, and our lawyers only receive a fee if a settlement or recovery is obtained for injuries caused by side effects of Uloric.