U.S. health regulators recently confirmed that Uloric is associated with an increased risk of heart-related death and all-cause mortality compared to other gout treatments. Filing a Uloric lawsuit may be an option if someone you love died while taking this drug.
The defective drug attorneys at Bernstein Liebhard LLP are offering free, no-obligation case reviews to individuals interested in filing a Uloric lawsuit on behalf of a deceased loved one. To learn more, please contact our office by calling (888) 994-5118.
Uloric (febuxostat) is indicated to treat adults suffering from gout, a form of arthritis caused by excessive amounts of uric acid in the blood. Takeda Pharmaceuticals obtained U.S. Food & Drug Administration (FDA) approval to market the drug in 2009.
Apparently, Takeda’s pre-market clinical trials suggested heart problems occurred more frequently in patients taking febuxostat compared to those taking allopurino (Zyloprim and Aloprim). Therefore, Uloric’s original label included a “Warning and Precaution” regarding the potential for cardiovascular events, such as:
The FDA also ordered Takeda to conduct an additional post-market safety study to better understand the heart risks potentially associated with febuxostat.
The FDA announced the conclusion of Takeda’s post-market study in November 2017.
According to the agency, the trial involved more than 6,000 adults who underwent treatment for gout with either Uloric or allopurino. Its primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.
“The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol,” the FDA said in a Drug Safety Communication published on November 15, 2017. “However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”
In January 2019, the FDA asked a panel of outside medical advisers to review data from Takeda’s post-market Uloric study.
Apparently, they agreed that the risk of febuxostat side effects outweighed its benefits for most patients. By a 12-to-2 vote, the members recommended that the drug remain a first-line treatment for a small number of gout patients, including those who can’t tolerate allopurinol. However, they suggested doctors limit Uloric to second-line status for all other patients.
Additionally, they advised the FDA to highlight the risk of heart-related death in a black box warning – the most serious safety warning — on the drugs label.
However, one of the two dissenting panel members voted to recommend a Uloric recall.
“It would allow the drug to be dispensed only under certain circumstances,” Steven M. Nissen, MD, MACC, told Cardiology Today. “It would be kept at a central pharmacy, and only dispensed if the doctor and patient gave informed consent that they are aware of the drug’s risks regarding CV death. The FDA was reluctant to agree to that, so I voted to remove the drug.”
Consequently, the FDA ordered a Black Box Warning for the Uloric label the following month. The agency also limited Uloric’s approved uses to patients who are unable to take allopurinol.
Gout patients considering Uloric should inform their doctor if they have history of heart problems or stroke. Those taking febuxostat should immediately seek emergency medical attention if they experience any of the following symptoms:
The FDA also required Takeda to create a new patient Medication Guide for Uloric. The Guide explains the heart risks with febuxostat and other important things patients need to know, including:
According to the agency, Uloric patients should read this Medication Guide EVERY TIME they receive a prescription.
You may be entitled to financial compensation if someone you loved died while taking Uloric, including payment for:
To learn if you are eligible to file a Uloric lawsuit, please call (888) 994-5118 to arrange for your free, no-obligation legal review.
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