FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

On November 15, 2017, FDA alerted the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (brand name Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009.

Source: FDA Drug Safety Podcasts - November 20, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts