In February 2019, the FDA included a box warning for the gout medicine Uloric. This warning addressed the fact that those taking the drug may be at a greater risk for heart-related and other types of deaths. Recently, attorneys have begun to file suits on behalf of those who have been injured by Uloric and their families. Currently, there are more cases that are in the investigatory phase and will likely be filed soon. Anyone who has suffered harm from Uloric or have had a loved one die while taking the medication should contact Rosenfeld Injury Lawyers to discuss their legal options.
Uloric was approved by the FDA for use to treat gout in 2009. Gout is caused by high uric acid levels in the blood, and Uloric is intended to lower those levels. Gout develops in part because the body is taking substances called purines that are found in food and drink and turns them into uric acid. Uloric is supposed to stop that process. Uloric is manufactured by Takeda Pharmaceuticals. The global market for the drug is estimated at just under $1 billion and continues to grow at an 11 percent annual rate.
When the FDA initially approved Uloric, it included a Warning and Precaution addressing the possibility of a cardiovascular event associated with use of the drug. However, at the time that the FDA approves a drug, there sometimes is only limited testing performed with some testing still to be done as the FDA requires. Here, the FDA directed Takeda to perform further studies about the possibility of cardiovascular deaths and events. The test results did indicate that there was a possibility of non-fatal and fatal heart attacks and stroke associated with the drug. Still, the FDA took no further action at the time.