Based on the results of the CARES study, Health Canada mandated an Uloric label change in early November 2019 which warns about an increased risk of Uloric-related cardiovascular deaths. Uloric is now only approved for use in Canada as a treatment “to lower serum uric acid levels in patients with gout who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate (a second-line therapy).”
That information is from this Health Canada document, “ULORIC ® (febuxostat) – Increased Risk of Cardiovascular Fatal Outcomes”, which goes to point out that a higher rate of cardiovascular deaths has been reported in patients with gout who also had cardiovascular disease when treated with Uloric, compared to those treated with the more-established gout drug allopurinol.
This recent drug safety regulatory action by Health Canada is similar to a Drug Safety Update for Uloric issued July 17, 2019 by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
We are investigating Uloric drug injury cases against Takeda Pharmaceuticals America, Inc., which is responsible for Uloric in the US. For additional information, you can see the Uloric Side Effects page on our Drug Injury Law website.[Read article in full at original source]