February 2019: Despite Safety Trial Finding A Link To Cardiac Deaths, FDA Does Not Order Uloric Recall At This Time
This new article about the gout drug Uloric (febuxostat) is an update for one we posted about six weeks ago, "Uloric Recall, 'Black-Box Warning', And Limited Use Discussed By FDA Advisory Committees In January 2019".
We start with an overview taken from a February 21, 2019 MedPage Today report, "FDA: Gout Drug Raises Death Risk":
The FDA concluded its months-long investigation into mortality risk with [Uloric (febuxostat)] by mandating strong warnings on the product label and restricting use.
Approved use is now only after maximally titrated [Zyloprim (allopurinol)] fails or isn't tolerated.
[Uloric (febuxostat)] will have to carry a black-box warning of increased risk of cardiovascular and all-cause mortality compared with [Zyloprim (allopurinol)], as had been shown in the CARES trial, and update the patient medication guide with that information.
FDA also recommended that clinicians monitor for cardiovascular signs and symptoms for patients on [Uloric (febuxostat)].
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For more detailed information, we go to the Data Summary part of this February 2019 FDA Drug Safety Communication, "FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)":
When FDA approved Uloric (febuxostat) in 2009, we included in the prescribing information a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric. We also required the drug manufacturer, Takeda Pharmaceuticals, to conduct a large postmarket clinical trial to evaluate the cardiovascular safety of Uloric.... The primary endpoint was a composite of major adverse cardiovascular events (MACE): cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina with urgent revascularization. Secondary endpoints included the individual components of the MACE composite as well as death from any cause. The study... [found] there was a significant increase in cardiovascular death....
This recent clinical trial finding was the basis for the FDA set forth in the Safety Announcement part of that FDA document:
The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.
As a result, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide. We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.
In summary, while there was no Uloric recall ordered, the FDA required its strongest safety warning, i.e., Bolded Warning or Black-Box Warning, for the Uloric drug label to inform about the increased risk of heart-related death and death from all causes with Uloric.
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