Public Citizen Wants Uloric Taken Off Market
Public Citizen says FDA should immediately require the removal from the market of all medications containing the widely prescribed xanthine oxidase inhibitor febuxostat (Takeda’s Uloric) because (1) febuxostat increases the risk of death compared with alternative therapies and (2) there exist other effective medications that had been approved by FDA for treating gout that have a lower risk of death.
“In summary, febuxostat has unique serious risks but no unique clinical benefit,” a petition filed by the group says, basing its analysis on results of a recent postmarketing study.
The petition notes that initial clinical trials strongly suggested an increased cardiovascular risk with febuxostat and appropriately led to the agency repeatedly denying approval of the NDA. However, it says, a later Phase 3 trial “of inadequate duration and power unfortunately provided temporary false hope that perhaps febuxostat was safe. Rather than follow the all-important precautionary principle of public health and require an appropriately designed trial to rigorously assess the cardiovascular risks of febuxostat before approval, FDA approved the drug and mandated a postmarket randomized controlled trial that was adequately powered to evaluate these risks. As a result, febuxostat has been aggressively marketed and prescribed to at least hundreds of thousands of patients over the past decade who were unaware of the potential dangers.”
According to Public Citizen, the results of the required postmarket trial “now provide additional high-quality evidence of a causal link between treatment with febuxostat and increased risk of all-cause death and cardiovascular death. FDA almost certainly would have denied approval of 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.”
In response to our request for comment, Takeda spokesperson Kara Hoeger said the company was aware of the petition but declined to comment. She noted that FDA will respond to the petition and also indicated that the company has been "proactive in sharing the CARES CVOT data with the medical community as well as FDA, first notifying them following the initial data analysis in October (2017). We've submitted the complete study data to FDA and are working with them to conduct a comprehensive review of this data."