Uloric was widely used as a first-line treatment for gout for almost 10 years. But in February 2019, the U.S. Food and Drug Administration limited use of the drug and required new warnings after a study exposed an increased risk of heart-related death with the medication. People who suffered serious cardiovascular events while taking Uloric and those who lost loved ones to heart-related death have begun filing lawsuits against the manufacturer.
Uloric was the first prescription medication in 40 years to gain U.S. Food and Drug Administration approval to treat hyperuricemia in adults with gout, and it quickly became a popular first choice to treat the severely painful condition.
But a clinical trial into the safety of febuxostat, the drug’s active ingredient, exposed an increased risk of death with the medication compared to a competing gout drug. The FDA responded in 2019 with a new label warning and by restricting who can take Uloric.
By the time the FDA required the changes, the drug had already been on the market for 10 years, and doctors had prescribed it millions of times.
Gout affects 8.3 million Americans, and few drugs are available to treat it. Uloric hit the market in 2009 and by June 2015, it was the 46th most-prescribed drug in the United States.
Takeda Pharmaceutical Company reported $1.9 billion in sales of the drug between 2012 and 2017. Doctors at one point had written 1.3 million prescriptions for the drug in the matter of just 12 months.
Status of Lawsuits
Uloric lawsuits are still in the very early stages. No major settlements have been announced, and no cases have gone to trial. Because of the large number of people who took the drug during the decade before the warnings were added to its label, there could potentially be hundreds or thousands of lawsuits.