What is Uloric and why is it so dangerous?
Made by the international conglomerate Takeda Pharmaceuticals, Uloric (febuxostat) is a medication that lowers uric acid levels in the blood. It was first FDA approved in 2009 as an alternative to treating gout with allopurinol. After approval, the FDA required Takeda to conduct a large post-market study of the gout medication to evaluate the cardiovascular safety of the medication.
According to the Agency, results from the 6,000 patient post-market study of gout treated with either Uloric or allopurinol showed that Uloric did not increase the risk of these combined cardiovascular events compared to allopurinol. However, when the outcomes were evaluated separately, Uloric showed a significantly increased risk of heart-related deaths and death from all causes.
The FDA is now taking steps to warn the public by updating Uloric’s prescribing information and medication guide as well as requiring a Boxed Warning, the FDA’s most prominent warning for pharmaceuticals.