Health Canada Issues New Warning for Uloric Heart Problems

Published on November 12, 2019 by Sandy Liebhard

Uloric (febuxostat) has lost first-line status in Canada, after a study suggested the gout treatment is associated with an increased risk of cardiovascular death and other heart problems.

Uloric Heart Problems: Background

Uloric is marketed by Takeda Pharmaceuticals to lower uric acid in patients suffering from gout, a painful form of arthritis.

Before Uloric gained regulatory approval in the United States or Canada, early clinical trials indicated those taking the medication might be more likely to experience life-threatening cardiovascular events, including heart attack, stroke, and heart-related death. As a result, Takeda was required to conduct a post-market study to better assess the potential for Uloric heart problems.

The results of that study were published in the New England Journal of Medicine in March 2018, and suggested that the risk of all-cause mortality and cardiovascular death were higher with Uloric compared to an older gout drug called allopurinol. Over the course of the trial, which involved gout patients with a history of major cardiovascular disease, cerebrovascular disease, or diabetes mellitus with micro- macrovascular disease, 134 deaths were recorded in the Uloric group, while just 100 occurred in the allopurinol group.

Health Canada Orders Uloric Label Update

The Uloric label in Canada will now include a Serious Warning and Precautions Box regarding the potential for cardiovascular death. Health Canada is also advising that doctors:

• Use Uloric only in adult patients with gout who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate (second line therapy).
• Not recommend Uloric treatment in patients with ischemic heart disease or congestive heart failure.
• Monitor for signs and symptoms of possible Uloric hearth problems including myocardial infarction, stroke and cardiac failure in patients who are taking febuxostat.

Uloric Lawsuits Follow FDA Warning

The U.S. Food & Drug Administration took similar action in February, when it ordered Takada to add a Black Box Warning to the drug’s label regarding the potential for heart-related death. The agency also demoted Uloric to second-line treatment status, and recommended doctors limit its use to patients who haven’t responded to or who are unable to tolerate allopurinol.

Since then, a growing number of Uloric lawsuits have alleged that Takeda could have issued these warnings much earlier. Because the company failed to do so and continued to market Uloric as a superior alternative to allopurinol, plaintiffs claim they and their doctors remained oblivious to the drug’s alleged defects and significant dangers.