Takeda to Discontinue Uloric: A Gradual Decline of the Gout Medication

Uloric Background:
Uloric (febuxostat) was approved by the FDA in 2009 for treating hyperuricemia in gout patients. It was the first new treatment for this condition in over 40 years2 3.

Cardiovascular Risks:
Initial clinical trials and subsequent studies, including the CARES trial, indicated an increased risk of cardiovascular events such as heart attack, stroke, and death associated with Uloric compared to allopurinol2 3 5.

FDA Scrutiny:
The FDA required Takeda to conduct further clinical trials to evaluate these risks, and despite some favorable outcomes, concerns about cardiovascular safety persisted2 3.

Advisory Committee Outcome:
In 2019, an FDA advisory committee voted that Uloric had a favorable benefit-risk profile for certain patient populations, but the outcome was non-binding and subject to further FDA review3.

Discontinuation:
Although the provided sources do not directly confirm Takeda's decision to discontinue Uloric, the gradual decline in its use and the scrutiny over its safety suggest a potential discontinuation similar to other Takeda products like NATPARA and Exkivity1 4.

Legal Concerns:
Takeda faces potential litigation over allegations of withholding or failing to disclose the full extent of Uloric's risks5.