The FDA has required its strongest safety warning, i.e., Bolded Warning or Black-Box Warning, be included on a new Uloric drug label to inform about the increased risk of heart-related death and death from all causes with Uloric.
From this February 2019 FDA Drug Safety Communication, “FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)”, we get the following:
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.
We will continue to monitor the safety of Uloric, with a particular focus on cardiovascular deaths, nonfatal myocardial infarctions or heart attacks, nonfatal strokes, and unstable angina with the need for urgent revascularization.
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