A 2011 Uloric lawsuit claimed Takeda hid serious side effects from the public. In February 2019, the FDA limited the use of Uloric and required new warnings after a clinical trial showed an increased risk of heart-related death with the gout drug. People who suffered serious cardiovascular events while taking Uloric have begun filing lawsuits.
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Uloric was the first prescription medication in 40 years to gain U.S. Food and Drug Administration approval to treat hyperuricemia in adults with gout, and it quickly became a popular first choice to treat the severely painful condition.
But a clinical trial into the safety of febuxostat, the drug’s active ingredient, exposed an increased risk of death with the medication compared to a competing gout drug. The FDA responded in 2019 with a new label warning and by restricting who can take Uloric.
By the time the FDA required the changes, the drug had already been on the market for 10 years, and doctors had prescribed it millions of times.
Gout affects 8.3 million Americans, and few drugs are available to treat it. Uloric hit the market in 2009 and by June 2015, it was the 46th most-prescribed drug in the United States.
Takeda Pharmaceutical Company reported $1.9 billion in sales of the drug between 2012 and 2017. Doctors at one point had written 1.3 million prescriptions for the drug in the matter of just 12 months.
Status of Lawsuits
Uloric lawsuits are in the very early stages. No major settlements have been announced, and no cases have gone to trial. The lawsuits allege that Takeda failed to warn patients of potential life-threatening side effects including heart attack, stroke and heart-related death. Other cardiovascular events likely to be named in lawsuits include deep vein thrombosis, angina and pulmonary embolism.
Because of the large number of people who took the drug during the decade before the warnings were added to its label, there could potentially be hundreds or thousands of lawsuits.
Lawsuits could be filed on behalf of patients or families of patients who took Uloric and later suffered major cardiovascular events.
FDA Warning: Increased Risk of Death
The FDA concluded in February 2019 that there is an increased risk of death with Uloric compared to another gout medicine called allopurinol. The agency required Takeda to add a black box warning to Uloric’s label to alert consumers about an increased risk of heart-related death as well as death from all causes with the medication.
Boxed warnings are the strongest warnings the FDA requires for drug labels.
“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.”
In addition, the FDA limited use of the drug to only patients for whom allopurinol didn’t work or caused side effects. Allopurinol is marketed under the brand names Zyloprim and Aloprim.
“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,” the FDA said in a safety alert.
The FDA advised patients to tell their doctor about any history of heart disease or stroke before they take Uloric. It also warned patients who take the drug to seek emergency medical attention if they experience symptoms of heart attack, stroke or other cardiovascular problems.
Clinical Trial Exposed Death Risks
At the instruction of the FDA, Takeda launched the CARES clinical trial after Uloric became available to patients in the United States. The New England Journal of Medicine published the results of the trial in March 2018. The findings exposed an increased risk of death with the gout drug.
The trial looked at 6,190 patients with gout who were given either febuxostat, which is the active ingredient in Uloric, or allopurinol. Researchers followed the patients for 32 months on average.
“Cardiovascular death and deaths from any cause were more frequent in the febuxostat group than in the allopurinol group. New England Journal of Medicine, March 29, 2018”
Researchers found that for every 1,000 patients who had taken febuxostat for a year, there were 15 heart-related deaths compared to 11 heart-related deaths for every 1,000 patients who had taken allopurinol for a year. When researchers looked at all causes of death, the rate was 26 deaths per 1,000 Uloric patients compared to 22 deaths per 1,000 allopurinol patients.
“Cardiovascular death and deaths from any cause were more frequent in the febuxostat group than in the allopurinol group,” the researchers wrote.
Petition Sought Uloric Ban
The nonprofit advocacy group Public Citizen petitioned the FDA to pull Uloric off the market following publication of the 2018 CARES clinical trial.
“There is overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit,” Public Citizen wrote in its petition.
The petition said Takeda aggressively marketed the drug to “hundreds of thousands of patients over the past decade who were unaware of the potential dangers.”
“There is overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit.”
The FDA denied the petition the same day it announced the new cardiovascular death risk warning in Uloric’s label. In its response to Public Citizen, the FDA said it determined there were still patients that the drug could help.
“Because of the limited treatment options available for gout and the risks associated with them, there are patients for whom the benefits of febuxostat outweigh the risks,” Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, wrote in the response letter to Public Citizen.
FDA Rejected Uloric Approval Twice
Before the FDA approved Uloric in 2009, it had twice rejected the drug in 2005 and 2006. Each time, the FDA asked for more data on cardiovascular risks.
At the time, the drug was being developed by a joint venture of Takeda and Abbott Laboratories.
The agency only approved the medication after Takeda had promised to launch the CARES safety trial and include in the drug’s label a warning of a higher rate of cardiovascular thromboembolic events with febuxostat.
Thromboembolic events can include strokes, deep vein thrombosis or embolisms.
Doctor’s Lawsuit Accused Takeda of Hiding Other Risks
Dr. Helen Ge claimed Takeda knew but kept quiet about cases in which Uloric made kidney problems worse for patients. The complaint also said the company had concealed reports of fatal interactions between the drug and autoimmune treatments as well as incidents of severe bleeding when patients took the drug with the blood thinner warfarin.
Not only did Takeda not warn of these interactions on the drugs’ labels, but also in some cases, the company did not report adverse events to the FDA, according to the complaint.
The lawsuit also claimed Ge was fired after she had recommended Takeda report the adverse events to the FDA and revise the drugs’ labels to warn of potential adverse events.
The U.S. District Court for Massachusetts dismissed the lawsuit in November 2012. The U.S. Supreme Court denied an appeal from Ge to hear the case in October 2014.
Please seek the advice of a medical professional before making health care decisions.