February 2019 Uloric Label Changes Include New "Black-Box Warning" To The Effect That Uloric Is Gout Drug Of Last Resort
As a result of recent FDA-mandated label changes for Uloric there have been lawsuits filed against Takeda Pharmaceuticals America, Inc., the manufacturer of Uloric. Those drug injury lawsuits allege that the drug company Takeda failed to warn Uloric users about the increased risks of heart attacks and strokes.
Uloric (febuxostat) tablets have been generally prescribed for the management of chronic gout since 2009.
In March 2019 we posted this article, "Uloric 'Black-Box Warning' For Increased Risks Of Heart-Related Deaths And Cardiovascular Side Effects".
This previous article explained that while there was no Uloric recall ordered, in February 2019 the FDA required its strongest safety warning, i.e., Bolded Warning or Black-Box Warning, for the Uloric drug label to inform about the increased risk of heart-related death and death from all causes with Uloric.
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In addition to this new Black-Box Warning for Uloric, the FDA required Takeda to make the following label changes:
- Modify the "Indications and Usage" part of their Uloric drug label; and,
- Add a new section (5.1) titled "Cardiovascular Death" to the "Warnings and Precautions" part of their Uloric drug label, which includes this language:
Physicians and patients should remain alert for the development of adverse [cardiovascular (CV)] event signs and symptoms. Patients should be informed about the symptoms of serious [cardiovascular (CV)] events and the steps to take if they occur.
For more background on this relatively new Uloric drug injury litigation, you can read our earlier articles about Uloric:
- "Uloric Recall, 'Black-Box Warning', And Limited Use Discussed By FDA Advisory Committees In January 2019" (January 2019)
- "Gout Drug Uloric Recall By FDA Requested In June 2018 Public Citizen Petition Letter" (July 2018)
- "Uloric Drug Safety Update: A Significantly Higher Risk Of Death Among Patients Using Gout Drug Uloric As Opposed To Allopurinol" (March 2018)
- "Gout Medicine Uloric Safety Trial Shows Increased Risk Of Heart-Related Deaths According To November 2017 FDA Alert" (November 2017)
Our law firm is investigating possible Uloric cases involving patients who have suffered cardiovascular problems while taking Uloric. If we can be of assistance to you or someone else as regards a personal injury or wrongful death Uloric lawsuit, you can submit an online Case Evaluation Form or call us toll-free: 800-426-9535.
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