In 2009, Uloric (active ingredient febuxostat) became the first prescription gout medication to gain FDA approval in 40 years. Doctors were quick to prescribe the new blockbuster drug, which has generated $1.9 billion in sales for manufacturer Takeda Pharmaceuticals within the last five years alone.
Then, in February 2019, the use of this medication was severely restricted with a new Black Box warning label and strict FDA guidance after a clinical trial revealed unusually high levels of heart-related mortality. People who suffered serious cardiovascular events while taking Uloric or who lost loved ones during treatment for gout have filed lawsuits claiming they were not alerted to the risks.
Gout Medications With Febuxostat Gain New Black Box Warning Label
The FDA recently updated the Uloric warning label with a Black Box Warning, the most prominent type. Following an in-depth review of a safety clinical trial, they found a 34 percent increased risk of cardiovascular death and a 22 percent increased risk of death from any cause when compared to gout medications containing allopurinol.
Some of the mortality can be attributed to patients who happened to be in worse physical condition; however, the FDA is recommending that physicians limit the use of Uloric to patients who fail to respond to allopurinol or suffer its adverse side effects.
Whistleblower Uloric Lawsuit Filed
A 2011 whistleblower lawsuit was filed by former Takeda contractor Dr. Helen Ge, who says the company hid the serious risks of drugs like Uloric, Prevacid, and Dexilant. She said she kept quiet about cases where Uloric worsened kidney problems, fatally interacted with autoimmune treatments, or caused severe bleeding when used with warfarin. Takeda failed to include any of these drug interactions on the warning label and did not report adverse events to the FDA.
Additional claims include allegations that Takeda modified documents sent to the FDA in order to gain approval.
Prior to 2009, the FDA had rejected Uloric approval twice, requesting more data on cardiovascular side effects. Though her case was dismissed in 2012 and denied an appeal in 2014, the new information available may prompt the Supreme Court to take another look.
New Lawsuit Alleges Heart Attack Caused by Uloric
Vermont Plaintiff Mark Gomez filed a lawsuit in the U.S. District Court for the Northern District of Illinois, alleging that Uloric caused a heart attack a few years after he began taking it for gout in 2015. After having a myocardial infarction in June 2017, Mr. Gomez suffered permanent injuries, including severe mental and physical pain and suffering. He seeks financial compensation to cover his ongoing economic losses and medical needs. Had he known of the risk, he would not have agreed to take the medication, his lawsuit stated.
Petition to Ban Uloric
Nonprofit advocacy group Public Citizen has petitioned the FDA to pull Uloric off the market following the results of the 2018 CARES clinical trial, stating: “There is overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit.” The petition charges Takeda with “aggressively marketing the drug to hundreds of thousands of patients over the past decade who were unaware of the potential dangers.”
What’s Next for Patients and Their Families?
The Uloric litigation is just starting to unfold, so there are no settlements or jury awards as of September 2019. However, the Gomez v. Takeda Pharmaceuticals lawsuit is far from the only complaint filed. Lawsuits are popping up nationwide.
It is possible we will see the Uloric lawsuits centralized into multidistrict litigation (MDL) as the number grows. The purpose of centralization is to streamline discovery processes, schedule bellwether trials to explore the strengths and weaknesses of similar central arguments, and reduce the cost of litigation. Following the bellwether trials, we may see a substantial settlement offer, or each of the trials remanded back to the courts where they were filed for individual jury trials.
In a strangely contradictory move, the FDA has also approved generic forms of febuxostat this year. Once again, the onus is on patients to take matters into their own hands to hold Big Pharma accountable and seek compensation for their losses.
You may have grounds for a lawsuit if you or a loved one took Uloric for gout and suffered cardiovascular issues like heart attack, stroke, angina, or heart-related death. Symptoms of heart attack and stroke include rapid or irregular heart rate, chest pains, breathing problems, difficulty with speech, numbness, or weakness on one side of the body, severe headaches, and dizziness. All of these symptoms should be checked out by a medical health care provider at once.
Call Showard Law Firm to determine if you are eligible to file a Uloric lawsuit. We offer free consultations and contingency-based representation, so you owe no legal fees unless your attorneys recover money on your behalf.