A prominent consumer group has condemned the U.S. Food & Drug Administration’s (FDA) recent decision allowing Uloric to remain on the market, despite mounting evidence of the gout drug’s potentially deadly heart risks.
“We are disappointed with the FDA’s reckless decision,” Michael Carome, M.D., the head of Public Citizens’ Health Research Group, wrote in a recent email to STAT News.
The group formally petitioned the agency to pull the medication from the market since last June, asserting that Uloric side effects – including heart attack, stroke, and cardiovascular death – outweighed its questionable benefits.
Gout occurs when too much uric acid crystallizes and forms deposits in the joints. Once known as the “Disease of Kings,” this painful form of arthritis has become increasingly common in the modern era, due to the prevalence of metabolic disorder, longer lifespans, and changes in diet. In fact, it’s estimated that roughly 8.5 million Americans currently suffer from gout.
The FDA approved Takeda Pharmaceuticals’ Uloric (febuxostat) in 2009. But because premarket clinical trials suggested febuxostat might increase cardiovascular risks, the agency also ordered Takeda to conduct a new study to better assess possible Uloric Side effects.
That study, known as the CARES trial, concluded in November 2017, and indicated patients taking Uloric faced a higher risk of health-related death and all-cause mortality compared to those taking another gout drug called allopurinol.
The FDA held an advisory panel meeting in January to discuss data from the CARES trial. During the meeting, Public Citizen’s Carome again urged the agency to recall Uloric.
“Before the FDA approved febuxostat, there was troubling evidence strongly suggesting that the medication increased the risk of serious adverse cardiovascular events and death,” he said in a statement issued ahead of the meeting. “The results of the FDA-mandated post-market trial now provide additional high-quality evidence of a causal link between treatment with febuxostat and an increased risk of death, particularly death from cardiovascular causes
The majority of panel members ultimately voted to keep Uloric on the market. However, they also advised the FDA to downgrade the drug to a second-line treatment for most gout patients, except those who can’t tolerate or previously failed to respond to allopurinol. And finally, they suggested the Uloric label should include a Black Box Warning to highlight potential heart risks.
The FDA formally rejected Public Citizen’s Uloric recall petition on February 21st, asserting that febuxostat remains the only alternative to allopurinol. The agency also ordered the Black Box Warning that same day and limited the drug’s use to patients who can’t use allopurinol
Public Citizen slammed the decision, asserting that it did not go far enough to protect patients from life-threatening Uloric side effects and insisting that there are safer alternatives when allopurinol is not an option.