Uloric LawsuitGout Medication Can Cause Cardiovascular Deaths

Uloric Lawsuit

Texas Woman Blames Uloric for Family Member’s Heart Attack

October 10, 2020 - A Texas woman recently filed a new Uloric Lawsuit in the U.S. District Court for the Northern District of Illinois. She filed the case individually and on behalf of the estate of her family member. She claims that after using the gout medication, the decedent suffered from serious injuries that led to her ultimate death.

According to the complaint, the decedent started taking Uloric in 2016. The drug manufacturer, Takeda Pharmaceuticals, represented the drug to be an appropriate treatment for gout.

The FDA approved Uloric in 2009 for use in the chronic management of uric acid buildup in patients with gout. At the time of approval, the FDA required a warning to be placed on the product label alerting doctors and patients to the possible increased risk of cardiovascular events.

Based on the results of an additional study, the FDA required Takeda to add a black box warning – the most serious type – to the product label, warning patients and doctors of the dangers.

In the complaint, the plaintiff alleges that “rather than doing adequate testing to determine the cause of these injuries or rule out Uloric’s design as the cause of the injuries, defendants continued to market Uloric as a safer and more effective prescriptive drug as compared to other available alternative treatments…”

Even after approval, the FDA required the company to perform a post-market study. The trial involved about 6,200 patients with gout and cardiovascular disease. Though the results showed overall rates of cardiovascular events were similar in patients taking Uloric, the difference was in the mortality rates.

The study was completed in 2017 and published in the New England Journal of Medicine in 2018. Yet the manufacturer did nothing to warn doctors and patients about the risks until required by the FDA in 2019.

Read More Updates

If you or a loved took Uloric and were subsequently diagnosed with cardiovascular injuries or other serious injuries, you may be entitled to compensation through a Uloric lawsuit. Contact a Uloric injury lawyer from TorHoerman Law today for a free, no-obligation consultation.

You can also use our chatbot below to get an instant online case evaluation  and find out if you qualify for the Uloric injury lawsuit today.

 

What is Uloric?

Uloric (febuxostat) is a prescription medication used to treat patients with gout which is caused by hyperuricemia, a condition that creates high uric acid in the bloodstream. Manufactured by Takeda Pharmaceuticals and introduced to the market with FDA approval in February 2009, Uloric was intended as an alternative to treating gout with Zyloprim (allopurinol). But, it managed to capture less than 10% of the treatment market and for good reason. There have been deadly side effects associated with the use of Uloric, such as cardiovascular-related deaths.

Uloric to Treat Hyperuricemia

Hyperuricemia is a condition that leads to too high of levels of uric acid in the body which can cause gout. Normally, uric acid is removed through urination. But, in individuals with hyperuricemia, excess uric acid remains which can cause urate crystals which then build up in joints, fluids, and tissues in the body. Hyperuricemia does not always cause gout, and without gout symptoms, the condition does not need to be treated. But, if symptoms such as intense pain, swelling, redness, or heat arise, immediately seek medical attention.

 

Uloric to Treat Goat

More than 8.3 million Americans suffer from gout. Gout is a form of inflammatory arthritis that can cause extreme discomfort and pain. It is very common for an individual to go between phases of flare-ups and remission. Uloric is one of the medications used to treat gout and it works by blocking the metabolic processes in the body that create uric acid. The blocking mechanism helps to prevent a build up of urate crystals which trigger gout.

 

 

Uloric Injuries

However, a link between Uloric and cardiovascular events, including sudden death, has been discovered prompting lawyers to look into a Uloric lawsuit.

It is highly recommended that only those individuals with severe renal dysfunction or those who cannot take Zyloprim (allopurinol) be prescribed Uloric because of the safety concerns.

Uloric injuries include, but are not limited to:

  • Cardiovascular injuries
  • Stroke
  • Liver damage (alleged)
  • Kidney damage (alleged)
  • Bone marrow failure (alleged)
  • Death

 

 

Uloric Post-Market Safety Clinical Trial Raises Question of Safety

Uloric was approved in 2009, yet the approval only came after two failed attempts at approval in 2005 and 2006. As a condition of approval and introduction to the market, the FDA required Takeda to conduct a postmarket safety clinical trial because of the continued questions and concerns surrounding Uloric.

As a result of preliminary results from the trial, the FDA issued a drug safety communication because of concerns of safety. The results of that trial showed an increased risk of heart-related death. During the trial, 6,000 individuals suffering from gout were treated with either Uloric or allopurinol. Those taking Uloric were found to have a higher rate of “heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery” compared to those taking the other gout medication.

 

Uloric Black Box Warning

In 2018, the FDA received the full trial report which, after months of in-depth reviews, prompted the FDA to issue an updated safety warning which included a black box warning, the most severe warning that can be issued. However, the FDA did not take the medication off the market which raised further concerns from individuals and doctors alike.

 

 

Whistleblower Uloric Lawsuit

A former safety consultant for Uloric manufacturer, Takeda Pharmaceuticals, issued a whistleblower lawsuit where he claimed the company knew about the risks associated with Uloric, yet failed to inform the public. The risks the company allegedly knew about include liver issues, kidney damage, and bone marrow failure.

Also included in the complaint was the allegation that Takeda knew that Uloric could be fatal when combined with select prescription drugs. It went even further to accuse the company of taking steps to conceal the dangers from the public. The lawsuit was eventually dismissed, but it raises bigger ethical questions surrounding Uloric and its manufacturer, Takeda.

 

 

Do I Qualify for a Uloric Lawsuit?

If you or a loved one was prescribed Uloric to treat hyperuricemia or gout and you were subsequently diagnosed with a cardiovascular injury or other serious injury, you may qualify for the Uloric lawsuit. Contact a bad drug lawyer from TorHoerman Law today for a free, no-obligation case consultation to find out about your legal options.

 

 

Filing a Uloric Lawsuit

Before filing a Uloric lawsuit, it is important that you mitigate your injuries – seek proper medical treatment, follow your doctor’s orders and do everything in your power to minimize the losses associated with your injuries.

You should then prepare for your Uloric lawsuit by learning more about the process of a civil lawsuit so you know what to expect of your litigation.

Finally, you should talk to an attorney about representing you as your Uloric injury lawyer. The choice of an attorney is one of the most important steps in your litigation. Be sure to find an attorney who is experienced and fully equipped to litigate on your behalf.

 

Hiring a Uloric Lawyer

Hiring a personal injury lawyer is an important step in the process of a Uloric lawsuit.

Your Uloric lawyer will work to build a case on your behalf by:

 

 

TorHoerman, Uloric Injury Lawyers

If a loved one suffered debilitating injuries or sudden death related to Uloric, TorHoerman Law is here to help you.

As a pharmaceutical drug law firm with years of experience under our belt, we are skilled in taking on the companies and manufacturers that have put people at risk by failing to warn of potentially deadly risks associated with a dangerous drug such as Uloric.

If you have any questions about the Uloric lawsuit, please feel free to contact us.

 

 


Litigation Updates

Second Drug Safety Communication Issued, Includes Black Box Warning

February 21, 2019 - The Drug Safety Communication released by the FDA stated there was an increased risk of death with the use of Uloric compared to Zyloprim (allopurinol). A black box warning for cardiovascular death and usage limited to only patients with symptomatic hyperuricemia.

 

FDA Held Meeting to Discuss Safety of Uloric

January 11, 2019 - As a result of a comprehensive study of the postmarket clinical safety trial, the FDA held a meeting with the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the repercussions and dangers of Uloric to those prescribed.

 

First Drug Safety Communication Issued by FDA

November 15, 2017 - The communication issued by the FDA revealed date from a clinical trial showed an increase in heart-related deaths. The study evaluated 6,000 individuals who were prescribed Uloric and suffered adverse cardiovascular events.

 

Uloric Approved for Use in the United States

2009 - Uloric, manufactured by Takeda Pharmaceuticals, was approved for use. However, lingering safety concerns prompted the FDA to only approve the drug on a contingency basis. Takeda would have to conduct a postmarket clinical safety trial to evaluate the safety of Uloric, and steps to issue additional warnings, or even withdraw it from the market, could occur if the risks of Uloric proved to be too dangerous.

References

"Drug Safety and Availability - FDA Drug Safety Communication: FDA to Evaluate Increased Risk of Heart-Related Death and Death from All Causes with the Gout Medicine Febuxostat (Uloric)." U.S. Food and Drug Administration Home Page, Center for Drug Evaluation and Research, 15 Nov. 2017, www.fda.gov/Drugs/DrugSafety/ucm584702.htm

"Gout | Arthritis | CDC." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 28 Jan. 2019, www.cdc.gov/arthritis/basics/gout.html

"Hyperuricemia (High Uric Acid)." Chemocare, Chemocare.com, chemocare.com/chemotherapy/side-effects/hyperuricemia-high-uric-acid.aspx.

Luhana, R. (2020, October 10). Texas Woman Blames Uloric for Family Member's Heart Attack. Retrieved October 20, 2020, from https://newyork.legalexaminer.com/health/texas-woman-blames-uloric-for-family-members-heart-attack/

Mayo Clinic Staff. "Gout." Mayo Clinic, Mayo Foundation for Medical Education and Research, 1 Mar. 2019, www.mayoclinic.org/diseases-conditions/gout/diagnosis-treatment/drc-20372903

Stott, Robert, et al. "FDA Adds Boxed Warning to Febuxostat for Increased Mortality Risk." Healio Rheumatology, Healio, 21 Feb. 2019, www.healio.com/rheumatology/gout/news/online/%7Bfe807284-bb20-4439-b657-a9332f886aaf%7D/fda-adds-boxed-warning-to-febuxostat-for-increased-mortality-risk

Last Modified: October 20th, 2020 @ 01:42 pm

What is Uloric?

Uloric is a medication used to treat very painful and debilitating gout. But, the U.S. Food & Drug Administration (FDA) recently issued a black box warning - the most severe warning the FDA can issue. Uloric has been linked to an increased risk of heart-related deaths.