Meyerson & Miller Attorneys at Law

Uloric Gout Medication Linked to Death,
Stroke, and Serious Heart-Related Injuries

A recent FDA analysis of the results of Takeda Pharmaceutical’s post-market safety clinical trial of Uloric determined that the product has an increased risk of heart-related events such as cardiovascular death, heart attack and stroke. As a result, in February 2019, the FDA determined it will require Uloric to carry a boxed warning or “black box warning,” the most severe warning the FDA can assign. The FDA warns that Uloric should not be prescribed to patients at high risk for cardiovascular events. Uloric (febuxostat) is a medication used to treat gout. As many as 8.3 million adults in the United States suffer from gout, and there are limited medications (the chief alternative to Uloric being allopurinol) used to treat it.

Uloric is a xanthine oxidase (XO) inhibitor, used to lower blood uric acid levels for adults with gout. Uric acid comes from a substance called “purines” in the body. When the FDA approved Uloric in 2009, it required Takeda Pharmaceutical to conduct a post-market safety clinical trial involving more than 6000 patients. While that study concluded that Uloric did not increase the risk of a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring intervention called unstable angina, further analysis showed that the drug did in fact increase the risk of each of those outcomes when considered separately.

Meyerson & O’Neill is investigating reports of serious cardiovascular injuries and deaths related to the use of Uloric. Patients who have used Uloric and suffered heart-related death, heart attack, stroke, or unstable angina, may be entitled to monetary compensation. For more information about your legal rights, please contact one of our experienced product liability lawyers immediately via our online form or call 888-773-3515 for a free and confidential consultation.
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