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The panelists came to the conclusion that for the general population with gout, the benefits of Febuxostat (Uloric) would not outweigh the risks (particularly cardiovascular events) when compared to Allopurinol, one of the standard treatments in patients with gout. In contrast, they proposed that the benefits of urate-lowering Febuxostat (Uloric) outweigh its risks for selected gout patients, though only for unrestricted access only as a second-line therapy, mostly for individuals who have had a serious skin reaction to or otherwise “absolutely don’t tolerate” Allopurinol, the mainstay xanthine oxidase inhibitor for uric acid reduction.
In this context, it is noteworthy that Febuxostat (Uloric)’s label already warns of increased risk of gout flares with initiation of therapy, cardiovascular events, hepatic toxicity, and serious skin reactions. Panelists further recommended several regulatory actions such as an additional black box warning and a change in the indication to label Febuxostat (Uloric) as a second-line therapy after Allopurinol only. They kept it open, if even a recall of Febuxostat (Uloric) could be considered.
Further to the status at the time of this writing, the FDA has now added a “Boxed Warning” to the drug label of Febuxostat (Uloric) due to the obvious increased risk of death for patients under Febuxostat (Uloric) and introduce a new, strengthened patient Medication Guide. FDA also limits the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with Allopurinol. See here the according safety communication by the FDA as of February 02, 2019.
See here an video introductory to gout: