The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a Uloric warning in July 2019 stating that patients with prior myocardial infarction, stroke, or unstable angina should avoid Uloric as there is a higher risk of death.
From this July 2019 MHRA Drug Safety Update, “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).
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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