Uloric Removed From Market Following Years of Concerns About Potential Health Risks

Years ago, critics said Uloric heart risks outweighed any benefits provided by the gout medication, calling for a Uloric recall in 2019.

Following more than five years of safety concerns about potential side effects from Uloric, and growing competition from other generic gout treatments, Takeda Pharmaceuticals has decided to remove Uloric from the market in the United States.

In an update on drug shortages published by the U.S. Food and Drug Administration (FDA) on January 22, the agency announced that Uloric has been discontinued. Takeda officials have stated the market removal was due to dropping sales amid competition from generic versions of the drug, but the move comes after critics previously called for a Uloric recall to be issued.

Uloric (febuxostat) was first approved in 2009, for the treatment of high uric acid levels in the body associated with gout. Amid aggressive marketing, the drug rapidly became a blockbuster treatment in the United States.

However, growing evidence has emerged that established a link between Uloric and heart risks, leading the FDA to require new warning information to be added to the drug label in 2019, and a number of Uloric lawsuits have been filed by former users of the drug, alleging they may have avoided a heart attack, stroke or other injuries by using a different treatment for gout.

According to Takeda, the launch of generic versions of Uloric resulted in only 3% of users actually buying and using the brand name version since 2019. However, those low sale numbers have been helped along by several FDA warnings over the years, which linked Uloric side effects to an increased risk of heart attack, stroke and other cardiovascular risks.

In February 2019, the FDA announced that the drug must carry the strongest label warning the agency can require a drug maker to place on their product, adding a Uloric “black box” warning about the risk of cardiovascular problems, which was not adequately reflected by the drug maker in the past.

This led to the consumer watchdog group Public Citizen to petition for a Uloric recall in 2019, which argued that the drug’s benefits treating gout did not justify the risk of dying from Uloric heart problems.

That same year, an FDA advisory committee meeting resulted in a 19 to 2 vote to advise the agency to make Uloric a second-line gout drug, meaning it was reserved for patients who had not responded positively to other gout medications first.

Takeda informed the FDA last year that it planned to discontinue the drug. However, to help patients’ transition to other medications, the company indicates it will continue to provide U.S. wholesalers with Uloric until March 31, 2026.