New Drug Safety Warning: Uloric Should Be Avoided When There Is Prior Myocardial Infarction, Stroke, Or Unstable Angina
From this Drug Safety Update issued July 17, 2019 by the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), "Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease", we get the following new Uloric warning:
Avoid treatment with [Uloric (febuxostat)] in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a phase 4 clinical study (the CARES study) in patients with gout and a history of major cardiovascular disease show a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to [Uloric (febuxostat)] than in those assigned to allopurinol.
In Europe, a so-called "Dear Doctor Letter" about Uloric side effects was sent out in late June 2019 by the drug company responsible for Adenuric, i.e., Uloric, in agreement with the MHRA and the European Medicines Agency (EMA).
The CARES study -- or the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial -- was conducted as an FDA requirement to determine whether Uloric was noninferior to allopurinol, a long-used gout drug, with regard to major cardiovascular events in patients with gout and cardiovascular disease.
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We have written previously about Uloric causing cardiovascular death, sudden cardiac arrest or sudden cardiac death, heart failure, myocardial infarction or heart attack, stroke, unstable angina with urgent coronary revascularization, and other heart-related problems.
Our three most recent articles from earlier this year are:
- 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)
Our law firm is investigating possible Uloric lawsuits where patients have suffered cardiovascular Uloric side effects as personal injury cases or wrongful death claims, depending on the outcome.
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