Drug Safety Warning: Watch For Myocardial Infarction, Stroke, And Cardiac Failure In People Who Are Taking Uloric
In early November 2019 Health Canada warned that in a post-market study, Cardiovascular Safety of [Uloric (Febuxostat)] and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (the CARES trial), 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.
Based on the results of the CARES study, Health Canada mandated an Uloric label change to the effect that 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 provide these details:
The [ULORIC drug label] was revised to enhance the safe use of ULORIC based on evidence identified in [the CARES trial]. This study was conducted to evaluate the CV risk of ULORIC in patients with gout who had a history of major CV disease, cerebrovascular disease, or diabetes mellitus with micro- and/or macrovascular disease. The study compared the risk of major adverse CV events between patients treated with ULORIC (N=3098) and allopurinol-treated patients (N=3092). There was a higher rate of CV death in patients treated with ULORIC (134 CV deaths of 3098) compared to patients treated with allopurinol (100 CV deaths of 3092). All-cause mortality was higher in the ULORIC group (243 deaths of 3098) than the allopurinol group (199 deaths of 3092) due to a higher rate of CV deaths (see Table 1 for details). Sudden cardiac death was the most common cause of adjudicated CV deaths in the ULORIC group (83 of 3098; 2.7%) as compared to the allopurinol group (56 of 3092; 1.8%).
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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), which we reported on in this article, "Uloric Use By Patients With Major Cardiovascular Disease Associated With Higher Risk Of Deaths".
Here is a list of our earlier 2019 Uloric articles:
- Uloric Lawsuits Involving Heart Attacks And Strokes Follow Recent FDA Warnings About Cardiovascular Deaths (April 2019)
- Uloric "Black-Box Warning" For Increased Risks Of Heart-Related Deaths And Cardiovascular Side Effects (March 2019)
- Uloric Recall, "Black-Box Warning", And Limited Use Discussed By FDA Advisory Committees In January 2019 (January 2019)
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.
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