“Emerging Uloric Litigation”
By Mark A. York (February 21, 2019)
(MASS TORT NEXUS MEDIA) Uloric made by Takeda Pharmaceuticals gained FDA approval subsequent to New Drug Application (NDA: 021856) in February 2009 and is now facing review by the FDA and others as to the risks associated with the drug.
Following an in-depth review of results from a safety clinical trial, the FDA has found that there is an increased risk of heart-related death and death from all causes with Uloric. Besides adding the Boxed Warning, the FDA is limiting the approved use of Uloric only to patients who have failed or do not tolerate another gout medicine Allopurinol.
Excerpt: [2-21-2019] 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.
As a result, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide. We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.
The FDA-mandated study, published in The New England Journal of Medicine in 2018, revealed 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”.
Takeda Pharmaceuticals is now under additional scrutiny as well as facing litigation if they withheld, altered or failed to properly disclose risk that that they were aware of, dating as far back to the initial clinical trials in 2009. Takeda is already facing legal problems over Uloric, with multiple Qui Tam lawsuits filed by a former safety consultant for the company. These suits that the company withheld information about dangerous side effects related to Uloric, including kidney problems, liver damage, bone marrow failure, drug interactions and more.
Gout, a type of arthritis that occurs when uric acid crystals build up in the joints. Gout has been found to be more common in men than in women Gout is believed affects about 8.3 million people, or 4% of the U.S. population.
Uloric was the first new drug approved to treat Gout in 40 years. Unfortunately, this new treatment which promised relief for those who suffer from Gout, appears to have numerous significant and potentially life threatening side effects that Takeda never warned the public about.
Initial clinical trials testing febuxostat prior to FDA approval linked the medication to possible increased risks of serious adverse cardiovascular outcomes, including heart attack, stroke and death. The FDA rejected the medication twice over these safety concerns before approving it in 2009 on the condition that the manufacturer conduct the now-completed large, post-market randomized clinical trial to further evaluate the cardiovascular risks.
Excerpt:[ 11-15-2017 ] The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information.
Febuxostat is FDA-approved to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Febuxostat works by lowering uric acid levels in the blood.
FDA Drug Safety Communication Re: Uloric Boxed Warning Added – Risk of Death
Takeda started post-marketing trials in 2009 and there are glaring issues with the trial results if Takeda had followed normal protocols.
Notably, 57% of the 6,198 enrolled patients left the trial prematurely, often when they encountered gout flares or thought they weren’t being taken good care of, explained lead investigator William White, MD, of UConn Health in Farmingdale, Connecticut, at the meeting. He noted that withdrawal occurred at the same rate in the febuxostat and allopurinol groups.
The CARES population not uncommonly had difficult problems like alcoholism and obesity and would commonly drop out when they felt like it, White said. “They’re ornery. They’re in pain all the time from the disease.” Such a large drop-out rate would have biased results to the null, which makes the observed cardiovascular mortality risk even more striking, according to panelist Bruce Psaty, MD, of the University of Washington in Seattle.
>To Learn More About the Emerging Uloric Litigation:
The Uloric Litigation will be used as a case study in the March 8-11, 2019 Mass Tort Nexus “Four Days to Mass Tort Success Course” in Fort lauderdale, FL. To register for the course, contact Jenny Levine at firstname.lastname@example.org or call (954) 520-4494.
Course attendees will receive the benefit of a step by step analysis of the emerging Uloric Litigation, using these primary metrics:
For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”
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