Following this discovery, the FDA added a new Medication Guide and a Boxed Warning for Uloric. This Black Box Warning, the most serious warning mandated by the FDA, includes a prominently placed label with crucial information. The label informs users and members of the medical community about the new increased risk of cardiovascular difficulties and related death from taking Uloric and combining medications while taking Uloric.
The new Medication Guide now shows the recent, limited approved use of Uloric. The FDA recommends that Uloric only be prescribed to specific patients who experience difficulties, ineffectiveness, or intense side effects when taking allopurinol.
The inception of concerns about Uloric began in 2012 when a previous Takeda Pharmaceuticals safety consultant, Helen Ge, filed a whistleblower lawsuit. Ge alleged in her lawsuit that by not reporting the dangerous side effects of Uloric when using it in combination with additional drugs, Takeda Pharmaceuticals defrauded both Medicaid and Medicare.