Uloric (febuxostat) was first approved by the U.S. Food & Drug Administration in 2009 to treat gout, a type of acute arthritis affecting roughly 8.3 million Americans. It works by lowering uric acid levels in the blood. When it hit the market, Uloric was the first prescription gout medication to gain approval in 40 years, and it quickly became a popular solution for this excruciating condition. More than a million prescriptions were written a year.
However, a decade later, a post-market safety trial revealed that the drug’s main active ingredient increased a patient’s risk of cardiovascular death and death from any cause. Now survivors and family members of the deceased are filing Uloric lawsuits against manufacturer Takeda Pharmaceuticals for their “failure to develop a safe product” and “failure to warn” of the risks. If you have any questions about a Uloric lawsuit, contact Bart Bernard. We offer free consultations and contingency-based representation in Louisiana and nationwide.
The most common Uloric side effects include gout flares, nausea, mild rash, and abnormal liver test results. These symptoms may clear up within a few weeks of starting the medication and are not necessarily serious. However, more severe adverse events have also been reported.
Uloric side effects associated with an adverse cardiovascular event include:
Adverse cardiovascular events associated with Uloric include heart attack, stroke, pulmonary embolism, angina, heart murmur, atrial fibrillation, and deep vein thrombosis. These side effects can be fatal.
Prior to approval, the FDA rejected the application for Uloric twice in 2005 and 2006, citing the need for more cardiovascular data. Upon initial approval in 2009, the FDA included a “Warning and Precaution” regarding
“possible cardiovascular events” in the prescribing information, and required manufacturer Takeda Pharmaceuticals to conduct a large post-market safety clinical trial. More than 6,000 patients taking Uloric or Allopurinol (Zyloprim) were included in the study.
In 2018, the results published in The New England Journal of Medicine revealed that gout relief was similar in both groups, but “cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group.” After one year of treatment, there were 15 heart-related deaths for every 1,000 patients — compared to 11 among Allopurinol users. Additionally, there were 26 deaths from any cause per 1,000 patients – compared to 22 for Allopurinol users.
On February 21, 2019, the FDA released a safety announcement that patients should “seek medical attention” if they experience adverse side effects. This information was placed in a Boxed Warning on Uloric packaging. FDA advisors recommended making Uloric a “second line treatment” for gout but did not initiate a recall at this time.
Uloric gout medication is manufactured by Takeda Pharmaceuticals. Based in Japan, Takeda is the largest drug-maker in Asia and one of the top 20 in the world. Last year, they brought in more than $19 billion from drugs like:
They are involved in Proton Pump Inhibitor lawsuits for Prevacid, along with AstraZeneca, the maker of Prilosec and Nexium. More than 4,000 patients who have filed lawsuits claim these drugs caused extreme complications like bone fractures and kidney disease.
Actos is another one of their controversial drugs. In 2015, Takeda agreed to settle more than 8,000 lawsuits for $2.4 billion. Patients alleged they developed bladder cancer, congestive heart failure, and other serious complications.
Uloric lawsuits are still in the earliest stages. Due to the large number of Americans who used the drug over the past decade, there could potentially be thousands of similar lawsuits flooding courts soon. Usually, when there is such a large number of lawsuits, they are consolidated into Multi-District Litigation (MDL) proceedings.
MDL proceedings would be good news for plaintiffs hoping for significant settlement amounts. Like a class action lawsuit, MDLs consolidate and streamline early discovery proceedings for expediency and efficiency. The same lead counsel prepares the basic facts of the case. Then several bellwether trials are selected to go before the same judge to identify the strengths and weaknesses of the central argument.
During the process, the manufacturer may offer plaintiffs a settlement, or they may opt to fight the lawsuits one at a time. Unlike a class-action lawsuit, where a large settlement is divided equally amongst all plaintiffs, MDL cases are heard separately in the courts where they were filed, with compensation awarded based on the amount of individual suffering.
Now is the ideal time to explore the possibility of filing a lawsuit pertaining to Uloric for gout. Contact Bart Bernard to explore your legal options. We never charge money upfront, and you only pay the standard legal fee if we secure compensation on your behalf.