The boxed warning follows a meeting of the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, which voted 19-2 that Uloric should be used exclusively as a second-line therapy for the treatment of hyperuricemia in patients with gout.
Public Citizen, a prominent consumer watchdog group, said the boxed warning does not go far enough, and that Uloric should be recalled nationwide immediately.
“We disagree with the panel’s vote and urge the FDA to withdraw febuxostat from the market,” said Michael A. Carome, MD, director of Public Citizen’s health research group.
Approved by the FDA in 2009, Uloric lowers uric acid in the blood and reduces sudden attacks of gout, a type of inflammatory arthritis. However, since its release, Uloric has repeatedly been linked to a large number of severe, potentially fatal cardiovascular side effects.
FDA is advising physicians to only prescribe Uloric to gout patients who have had unfavorable results with allopurinol, another prescription medication sold under the brand name Zyloprim.
Prior to the new warning, Uloric labels carried a warning about an increased risk of cardiovascular events compared to Zyloprim, the only other gout medication available at the time.