A prominent consumer watchdog group is calling for a Uloric recall to be issued by federal drug regulators, due to the growing scientific evidence that indicates side effects of the gout drug may increase the risk of heart attack, stroke and death.
Public Citizen urged a panel of FDA advisers to tell the agency to ban Uloric (febuxostat) at a recent hearing over the drug’s safety issues, saying that it provides no real benefits and increases the risk of dying from cardiovascular causes.
On Monday, the FDA’s Arthritis Advisory and Drug Safety and Risks Management Advisory committees held joint hearings on Uloric safety risks, ending in a 19 to 2 vote advising the agency to make it mostly a second-line drug for those who cannot tolerate other gout medications. The panel determined that Uloric’s heart risks were too high for most patients, but that a small population could potentially make use of the drug.
Uloric is used to help lower uric acid in patients with gout. However, post-market clinical trials indicate patients who take Uloric face an increased risk of suffering death from cardiovascular problems, such as heart attack or stroke.
For that reason, the FDA panel recommended Uloric be used as second-line treatment for general gout patients, and only as a first-line treatment in specific cases. However, a Uloric recall was not recommended by the panel.
While the FDA is not required to follow the recommendation of the advisory committee, the agency typically does.
Public Citizen called for a complete Uloric recall, and filed a petition (PDF) to have the drug banned from the market due to its health risks back in June 2018. Dr. Michael Carome, director of Public Citizen’s Health Research Group, submitted testimony (PDF) to the FDA advisory committees last week, calling for the advisers to recommend FDA act on his group’s petition.
In his testimony, Carome noted that the FDA had concerns about Uloric before it was even approved, resulting in post-marketing study requirements which appear to confirm high heart risks due to Uloric side effects.
Carome noted that the FDA would have almost certainly denied approval to the drug if it had known about the heart problems before it hit the market.
“The results of the FDA-mandated postmarket trial provide additional high-quality evidence of a causal link between treatment with febuxostat and increased risk of all-cause death and cardiovascular death,” he noted. “Consistent with the precautionary principle of public health, we strongly urge the committee to recommend that the FDA grant our citizen petition and remove febuxostat from the market.”
On Monday, panel members agreed with Carome that if the data from the recent clinical trial was available in 2008, when the drug was first approved, Uloric wouldn’t have been approved at all.
Concerns regarding the gout drug were raised after the FDA issued a safety warning in 2017. The warning indicated the agency was investigating deaths linked to Uloric, including cardiovascular deaths and deaths related to interactions with other drugs, including bone marrow failure, severe bleeding and kidney failure.