FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Consumer Group Calls for Withdrawal of Takeda’s Gout Treatment

June 25, 2018
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Public Citizen is urging the FDA to take Takeda’s Uloric and all products containing febuxostat off the market after the recent release of a post-market study claiming the gout treatment poses serious risks to patients and offers no unique benefits compared to other lower-risk medications.

In a petition filed Thursday, the advocacy group argues there is “strong confirmatory evidence” of harm from using Uloric. For example, in November, 2017, the FDA issued a drug safety alert stating that preliminary results from the required post-market trial showed “an increased risk of cardiovascular-related death and all-cause death with febuxostat compared with allopurinol.” The agency recommended that health care professionals consider the safety alert when deciding whether to prescribe or continue treatment using Uloric.

In addition, the results of a post-market clinical trial, published by White et al. in the New England Journal of Medicine in March, demonstrate “non-inferiority in terms of the primary composite cardiovascular outcomes endpoint but higher all-cause and cardiovascular mortality in febuxostat-exposed subjects” as opposed to allopurinol-exposed subjects, the organization said.

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