Uloric is a medication used to treat a type of arthritis in adults called gout. When the FDA was considering Takeda Pharmaceutical’s request to approve Uloric for use in the U.S. in 2009, it expressed concern with the likelihood that Uloric could cause heart problems. The FDA refused to approve the dose levels that the Takeda Pharmaceutical Company had requested. Instead, the FDA included a warning on Uloric’s marketing label that mentioned the possibility for Uloric to cause cardiovascular problems.
The FDA also required Takeda to conduct a postmarket clinical trial to test whether Uloric carried a risk of cardiovascular problems for people who took it to treat gout. This clinical trial was supposed to begin on January 31, 2010, and be submitted to the FDA five years later. However, the results were not released until June 14, 2018, only a short time before Takeda’s patent protection for Uloric in the U.S. was set to expire.
After this clinical trial, the FDA has updated Uloric’s warning label. The new warning label for Uloric included a box warning that prominently warned doctors and patients about the risks of developing a potentially fatal heart condition from taking Uloric.