FDA orders boxed warning on packaging after studies confirm death risks
DALLAS – National law firm Fears Nachawati is launching an immediate investigation into the popular gout drug Uloric, manufactured by Takeda Pharmaceuticals (NYSE: TAK), after the U.S. Food and Drug Administration (FDA) issued a boxed warning stemming from the increased risk of death from Uloric use.
On Feb. 21, 2019, the FDA concluded that there is an increased risk of death from Uloric (febuxostat) compared to another gout medicine, Zyloprim (allopurinol.) This conclusion is based on the FDA’s in-depth review of results from a clinical safety study, which found a higher risk of heart-related deaths when taking Uloric.
The FDA ordered a boxed warning be put on Uloric, as well as a new patient medication guide. The FDA is also limiting the approved use of Uloric to certain patients who either have an adverse reaction to allopurinol or for whom that drug has not been an effective treatment.
“It’s hard to believe that a medication meant to help could actually end lives,” said firm co-founder, Majed Nachawati.
Fears Nachawati law firm is now investigating possible Uloric lawsuits. The firm has a history of working with patients who have suffered from the effects of dangerous drugs and medical devices, such as hernia mesh, Invokana, IVC filters, opioids and Taxotere. The firm has built a significant reputation among the plaintiffs’ bar for seeing cases through to the end of litigation and fighting for clients’ rights.
The FDA approved Uloric in 2009 for the chronic management of hyperuricemia, which occurs when there is too much uric acid in the bloodstream. High uric acid levels can lead to several diseases, including gout, a painful type of arthritis.
In March 2018, it was announced that Uloric was inexplicably linked to more cardiac deaths than was allopurinol, the drug typically given to patients with gout and cardiovascular disease. Before that announcement, the FDA requested that Uloric be removed from the market in a drug recall in November 2017.
If someone you know has passed away after using the gout medication Uloric, please contact Fears Nachawati at 866-705-7584 to discuss a potential Uloric lawsuit.