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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.
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.
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.
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.
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 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.
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.
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.
If a loved one suffered debilitating injuries or sudden death, TorHoerman Law can help you through the next steps. 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 contact our personal injury firm.
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.
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.
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.
"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.
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: January 29th, 2020 @ 04:20 pm
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.
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