Public Citizen Pressures FDA to Pull Febuxostat Save

Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to remove Takeda's drug febuxostat (Uloric) from the market, citing the FDA's own warnings and evidence of serious cardiovascular harms (compared with allopurinol use).

In November 2017, the FDA issued a safety alert regarding regarding febuxostat and increased risk of cardiac death (compared to allopurinol users). This was based on comparative 6000 patient safety trial wherein febuxostat showed an increased risk of cardiac-related deaths and death from all causes. (Citation source:http://bit.ly/2IuDIR5) 

At the initial submission, FDA did not approve febuxostat over concerns of an imbalance in CV risk with the drug (compared to allopurinol). This led to a larger safety trial, the CONFIRMS study, (Citation source: http://bit.ly/2KcB7Be) that showed contrary to other phase III results, the risk of CV events with febuxostat were the same as or lower than allopurinol. Nonetheless, the drug was saddled with warnings about possible cardiovascular events.

"Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with ULORIC than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke."

According to IMH Health, from June 30, 2014 through June 30, 2015, Uloric was the 46th most-prescribed brand-name drug in the U.S., with 1.3 million prescriptions. The company reported $1.9 billion in U.S. sales from 2012 through 2017.

In March 2018, The New England Journal of Medicine published the results of another safety study that looked at the comparative cardiovascular safety of febuxostat vs. allopurinol (Citation source: http://bit.ly/2Kp1OPb). This trial showed febuxostat to have higher all-cause mortality and cardiovascular mortality compared to allopurinol.

The FDA will review the Public Citizen petition.