Uloric Lawyers Are Reviewing Cases Nationwide
Uloric (febuxostat) was introduced by Takeda Pharmaceuticals in 2009, and aggressively marketed for treatment of gout, resulting in widespread use over the past decade. However, it now appears that the drug maker has known for years that users face a serious risk of Uloric heart problems, yet failed to provide adequate warnings.
In February 2019, the FDA required a new “boxed” warning about the increased risk of cardiovascular events and death on Uloric when compared to use of the other gout drug, allopurinol (sold under brand names Zyloprim or Aloprim).
As a result of these Uloric side effects, use of the drug was restricted and patients are now informed to seek immediate medical attention if they experience symptoms of a heart attack, stroke or other cardiovascular problems.
If earlier warnings and information had been provided about the potential heart risks, many severe and life-threatening injuries may have been avoided. As a result, financial compensation may be available through a Uloric lawsuit for individuals who experienced problems.
The product liability lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations to help determine whether you or a loved one may have a case. To learn more, call 1-800-522-0102 or request a free case review.
Uloric Side Effects
Takeda Pharmaceuticals introduced Uloric in 2009, for the treatment of gout, which is a painful form of arthritis that impacts 8.3 million adults in the United States.
The drug works by lowering uric acid levels in the blood, and quickly grew to become a blockbuster gout drug, generating over $1 billion in annual sales.
However, before the drug was ever introduced, it appears that Takeda knew or should have known about the potential link between Uloric and heart side effects, yet continued to market the drug without adequate warnings.
In 2012 a former employee, Helen Ge filed a whistleblower lawsuit over Uloric, claiming Takeda Pharmaceuticals had defrauded the government by failing to warn about the risk of death associated with the medication, especially when used with some other drugs, such as digoxin, a heart medication, and warfarin, a blood thinner. The whistleblower also warned that Takeda altered and falsified adverse event reports to hide potential side effects, which was designed to make Uloric appear more competitive against allopurinol, which is used in competing gout medications like Zyloprim.
As a result of concerns about the potential cardiovascular risks with Uloric, Takeda was required to complete a post-marketing clinical trial, comparing the drug to allopurinol. According to findings:
- Cardiovascular death risk was 34% higher on Uloric
- All cause death risk was 22% higher on Uloric
As a result of the findings, the FDA launched a safety investigation in November 2017, to evaluate the reports of deaths linked to Uloric side effects.
Although some drug safety experts recommended that a Uloric recall be issued at hearings in January 2019, the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 19 to 2 to recommend that the agency restrict Uloric to a second-line drug, prescribed only if patients could not tolerate, or did not respond to, other gout medications, and then only for a select group of patients.
A month later, in February 2019, the FDA announced it was requiring a “boxed warning” be added to the Uloric label, to alert patients and doctors of the increased risk of heart problems and death.
Users are now warned to seek immediate medical treatment if they experience symptoms of a heart attack, stroke or cardiovascular problems on Uloric, including:
- Chest Pain
- Shortness of Breath
- Rapid or Irregular Heartbeat
- Numbness or Weakness on One Side of the Body
- Trouble Talking
- Sudden Severe Headaches
It appears that the manufacturer knew, or should have known, that their gout medication increased the risk of heart problems or death for years, but failed to adequately warn patients and doctors of the risks in an effort to maximize profits at the expense of patient safety.
As a result, Uloric settlements may be available for individuals who have suffered heart attacks, strokes, or lost loved ones due to a wrongful death.
If you, a family member of loved one suffered injuries or death due to the use of Uloric, request a free consultation and claim evaluation. All claims are handled on a contingency fee basis, meaning there are never any out of pocket expenses, and our attorneys are only paid out of any recovery achieved through a Uloric settlement or trial verdict.
Timeline of Uloric Problems
University of Chicago researchers compare Uloric, which is experimental at the time, to Zyloprim, and identified a potential increased risk of death.
FDA approves Uloric for the treatment of gout, and requires Takeda Pharmaceuticals to complete a large post-marketing study to further study the heart risks compared to allopurinol
A whistleblower files a Uloric lawsuit against Takeda, indicating that the drug maker has withheld information about the side effects.
FDA issues drug safety communication announcing an investigation into reports of death linked to Uloric during a clinical trial designed to evaluate the cardiovascular risks.
Researchers with the University of Connecticut, University of Chicago, and Johns Hopkins release the findings of a clinical trial, which warns that Uloric increases the risk of all-cause mortality in patients when compared to other gout drugs.
The consumer advocacy group Public Citizen urges the FDA to initiate a Uloric recall, indicating that the risks outweigh the benefits.
Two FDA advisory committees vote overwhelmingly to recommend that Uloric be restricted to a second-line therapy for a select group of patients.
February 21, 2019
The FDA requires a new Uloric “black box” warning about the risk of cardiovascular injury and death. It is the strongest label warning the agency can require a drug to carry.
Allegations Raised in Uloric Class Action Lawsuits
The attorneys at Saiontz & Kirk are reviewing potential claims of heart injury and wrongful death linked to the side effects of Uloric. According to allegations that will be raised, the pharmaceutical company has:
- Failed to properly research the Uloric side effects before introducing the drug;
- Failed to promptly follow through on studies to investigate the potential Uloric cardiovascular risks;
- Failed to provide accurate Uloric warnings for consumers and the medical community;
- Failed to issue a Uloric recall or safety warnings about the risks users face at certain doses;
No Fees or Expenses Unless You Receive a Uloric Settlement
Saiontz & Kirk, P.A. is a nationally known injury law firm that is focused exclusively on representing individuals, we do not represent corporations or insurance companies.
Over the course of more than 40 years, clients of our law firm have collected more than $1 billion in compensation in cases involving product liability, medical malpractice, automobile accidents and other personal injury lawsuits.
All Uloric cases are being handled on a contingency fee basis, which means that there are never any out-of-pocket costs to hire our lawyers and we receive no fees or expenses unless a recovery is obtained.
Protect your family and find out if you or a loved one may be entitled to a Uloric heart injury settlement.