The consumer advocacy group Public Citizen asserts that a FDA Uloric recall is necessary following results of a large postmarketing study that showed higher rates of fatal cardiovascular (CV) events and all-cause mortality in patients taking the drug. More exactly, it is the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidity (CARES) clinical trial results which are pointed out by a June 21, 2018 Public Citizen petition letter sent to the FDA.
Details about this Uloric recall request submitted to the FDA are set forth in Public Citizen’s June 21, 2018 Citizen Petition. Here are two such excerpts:
(1) On November 15, 2017, the FDA issued a drug safety communication alerting the public that preliminary results from the FDA-mandated post-market randomized controlled trial to assess the safety of [Uloric (febuxostat)] showed an increased risk of cardiovascular-related death and all-cause death with [Uloric (febuxostat)] compared with allopurinol. The agency recommended that “[h]ealth care professionals should consider this safety information when deciding whether to prescribe or continue patients on [Uloric (febuxostat)].”
On March 12, 2018, White et al. published the results of the postmarket clinical trial in The New England Journal of Medicine online, which demonstrated non-inferiority in terms of the primary composite cardiovascular outcomes endpoint but higher all-cause and cardiovascular mortality in [Uloric (febuxostat)]-exposed subjects than in allopurinol-exposed subjects. [footnotes omitted]
(2) The results of the FDA-mandated postmarket trial now provide additional high-quality evidence of a causal link between treatment with [Uloric (febuxostat)] and increased risk of all-cause death and cardiovascular death. The FDA almost certainly would have denied approval of [Uloric (febuxostat)] if data from this postmarket trial had been available at the time of the initial NDA submission, and the appropriate course of action now is obvious. We therefore request that the FDA remove from the market all medications containing [Uloric (febuxostat)].
Uloric was initially approved by the FDA in 2009.
Our law firm is currently investigating possible Uloric drug injury lawsuits against Takeda for which we are offering free case evaluations for patients and their family.[View article at original source]