On January 10, 2019 the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee panelists discussed the potential biological mechanisms behind cardiovascular (CV) events associated with Uloric (febuxostat) use.
From this January 11, 2019 MedPage Today report, “Make Uloric Second-Line for Gout, FDA Advisors Say”, we get this report of the two Advisory Committees meeting:
Members voted 19 to 2 (with one abstention) that a patient population exists for whom febuxostat’s benefit-to-risk profile is favorable in its current indication as first-line treatment for hyperuricemia in gout, despite a known link to cardiac deaths.
This includes 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, suggested Steven Nissen, MD, of the Cleveland Clinic and a panelist at the meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
“For everybody else, for the general population with gout, I would say that in those people the benefits do not outweigh the risk,” he cautioned….
“If a [Risk Evaluation and Mitigation Strategy (REMS)] can’t be developed, I would favor withdrawal,” Nissen responded. Other panelists called for boxed warnings but stopped short of calling for febuxostat to be withdrawn because of cardiovascular mortality, the mechanism for which remains unclear.
Uloric was approved by the FDA in 2009 for the chronic management of hyperuricemia in patients with gout. Now, in 2019, there may be an Uloric recall.
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