Following recent FDA-mandated label changes, there have been Uloric lawsuits filed against Takeda Pharmaceuticals America, Inc., the manufacturer of Uloric.
Uloric (febuxostat) tablets have been generally prescribed for the management of chronic gout since 2009.
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.
Further, 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.
Our law firm is investigating possible Uloric lawsuits for patients who have suffered cardiovascular side effects such as strokes or heart attacks while taking Uloric. If we can be of assistance to you or someone else as regards a personal injury or wrongful death case, you can submit an online Uloric Case Evaluation Form or call us toll-free: 800-426-9535.[View article at original source]