Nonprofit advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to pull Takeda Pharmaceuticals' gout drug Uloric (febuxostat) from the market after a postmarketing study of the drug found higher rates of fatal cardiovascular events and all-cause mortality in patients taking the drug.
In a citizen petition
filed Thursday, Public Citizen writes there is "overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit," citing the results of a postmarketing study
in more than 6,000 patients published in the New England Journal of Medicine
FDA initially rejected Takeda's new drug application (NDA) for Uloric twice—once in 2005 and again in 2006—both times citing concerns over cardiovascular risks and asking the company for additional safety data.
When it ultimately approved Uloric after a third NDA submission in 2009, FDA required
Takeda to conduct a randomized, controlled postmarketing study to determine whether the drug has a higher risk of serious adverse cardiovascular outcomes compared to allopurinol, a widely used gout treatment that has been on the market since 1966.
FDA also required a warning in the drug's labeling
advising that a higher rate of cardiovascular thromboembolic events was observed in patients treated with Uloric in clinical trials.
Based on preliminary results from the postmarketing study, FDA issued a safety communication
last November alerting patients and physicians that Uloric "showed an increased risk of heart-related deaths and deaths from all causes."
Then in March, Takeda announced the publication of its postmarketing study, noting that while the rate of major cardiovascular adverse events was similar between patients treated with Uloric and those treated with allopurinol, the rate of cardiovascular deaths was higher in patients treated with Uloric.
In a statement to Focus
, Takeda representative Kara Hoeger said the company has "been proactive in sharing the findings with FDA and the medical community," that the company is working with FDA to "conduct a comprehensive review" of the complete study data it submitted to the agency in January.