Current Uloric Drug Label Includes Warnings About Cardiovascular Events Such As Heart Attacks And Strokes Based On Pre-Approval Trials
Uloric (febuxostat) is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout, which is a type of arthritis. This gout drug works by lowering uric acid levels in the blood.
Uloric is manufactured by Takeda Pharmaceuticals, and was initially approved by the FDA in 2009.
On November 15, 2017 there was an email sent by the FDA about this MedWatch Safety Alert, "Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death", from which we get this excerpt:
ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009. Once the final results from the manufacturer are received, FDA will conduct a comprehensive review and will update the public with any new information.
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That page had a link to "FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)", from which we get this additional information:
The [Uloric (febuxostat)] drug labels already carry a Warning and Precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with [Uloric (febuxostat)] compared to allopurinol. These problems included heart attacks, strokes, and heart-related deaths. As a result, we required an additional safety clinical trial after [Uloric (febuxostat)] was approved and on the market to better understand these differences, and that trial was finished recently.
The safety trial was conducted in over 6,000 patients with gout treated with either [Uloric (febuxostat)] or allopurinol. The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. The preliminary results show that overall, [Uloric (febuxostat)] did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, [Uloric (febuxostat)] showed an increased risk of heart-related deaths and death from all causes.
We are continuing to evaluate this safety issue and will update the public when we have more information....
The current version of the Full Prescribing Information document, or drug label, for Uloric (accessed 11/15/17), at Part 5, WARNINGS AND PRECAUTIONS, includes this
5.2 Cardiovascular Events
In the randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with ULORIC (0.74 per 100 P-Y [95% Confidence Interval (CI) 0.36-1.37]) than allopurinol (0.60 per 100 P-Y [95% CI 0.16-1.53]) [see Adverse Reactions (6.1)]. A causal relationship with ULORIC has not been established. Monitor for signs and symptoms of myocardial infarction (MI) and stroke.
We will be watching for the FDA update which should be issued after the FDA has more information about this Uloric safety issue involving an increased risk of heart-related deaths and death from all causes. Further, depending on the results of the this FDA safety evaluation, there may be a drug label change with stronger warnings about these cardiovascular problems being Uloric side effects.
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