Uloric Cardiovascular Injuries – Heart Attacks & Strokes
Gout drug lawsuits are being filed over Uloric, a medication designed to help treat chronic gout. A Uloric gout drug lawsuit alleges the maker of Uloric failed to warn users of the increased risk of heart attacks and strokes. Our law firm is representing people who have suffered cardiovascular issues while taking – or after taking – Uloric for at least 30 days.
Uloric Drug Lawsuits
Uloric (Febuxostat) is a xanthine oxidase inhibitor prescribed for the management of chronic hyperuricemia (excess uric acid) in adult patients suffering from gout. Takeda Pharmaceuticals brought Uloric to the market after it received FDA approval in February 2009.
When the FDA approved Uloric in 2009, the agency required a warning label to include the information that it raised risk of cardiovascular events. The FDA also required Takeda to perform a mandatory post-marketing cardiovascular safety study.
The 6,000-patient safety trial saw its results published in the New England Journal of Medicine on March 12, 2018. The study’s authors found a statistically significant increased risk of cardiovascular death for users of Uloric compared with users of allopurinol.
Gout Symptoms & Causes
Gout is a form of arthritis characterized by sudden, severe attacks of pain, swelling, redness, tenderness in the joints. Pain and swelling often manifest in the in the feet and toes. The pain and swelling are caused by elevated uric acid levels in the bloodstream.
Patients with hyperuricemia and gout already face an elevated risk of cardiovascular events. The cause is not entirely understood, but may be linked to chronic inflammation associated with the underlying disease process. Most gout patients also suffer from various comorbidities which are also associated with an increased risk for cardiovascular events.
Gout is a disease state for which only a few medical therapies are available. Allopurinol has long been the standard of treatment. Brought to market first by Casper Pharma LLC in 1966, allopurinol has an established safety profile and has been available in generic form since at least September 1984.
Uloric is indicated only for those patients with severe renal dysfunction or those who cannot tolerate allopurinol. By comparison, allopurinol is at least as efficacious as Uloric, if not moreso, and it costs far less.
Uloric Lawsuit Compensation
For those who have experienced a heart attack or stroke while taking Uloric, we pursue damages for several losses. They include:
- Past and future medical and funeral expenses resulting from injuries.
- Past and future pain and suffering for injuries, treatment and recovery processes.
- Past and future wage loss, and loss of estate.
- Past and future loss of earning capacity.
- Past and future loss of enjoyment of life.
- Punitive damages, if applicable and warranted.
FDA Science regarding Uloric
On November 15, 2017, the FDA issued a Drug Safety Communication to the public:
“[P]reliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol” and noted it would be conducting a comprehensive review of Uloric’s safety.
The FDA held a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee on January 11, 2019, during which the safety of Uloric was discussed. While the committee agreed that biological plausibility for cardiovascular death was unclear, they “agreed that there is a consistent signal of cardiovascular death associated with febuxostat”.
Most committee members agreed Uloric should no longer be designated as a first-line therapy for gout. Most agreed Uloric should be reserved for patients who cannot tolerate allopurinol or who found allopurinol ineffective. Most members also noted Uloric should not be used in the general gout population or in patients with a history of cardiovascular events or those at high risk for cardiovascular events.
Uloric Boxed Warning
The FDA issued a second Drug Safety Communication re: Uloric on February 21, 2019. The agency announced there was an increased risk of death associated with Uloric when compared with allopurinol. Consequently, the FDA required the addition of a boxed warning for cardiovascular death. It also required a Limitation of Use, which reserved treatment only for those patients with symptomatic hyperuricemia.