Febuxostat—commonly sold under its brand name of Uloric—is a xanthine oxidase inhibitor used for treating gout—a condition caused by excessive levels of uric acid in an individual’s bloodstream (hyperuricemia) that crystalizes within the body and negatively affects kidney function and urine excretion. Uloric is prescribed to lower uric acid levels in the body and thus help manage adverse symptoms due to uric buildup. Uric acid forms as a result of an individual’s body metabolizing certain chemicals and toxic compounds and/or having difficulty in processing these toxins. Gout is often generally characterized as an arthritic condition, with clinical indications of pain, joint tenderness, inflammation, and malaise.
Uloric was brought to market in February 2009 as an alternative treatment for gout symptoms unmanageable by Zyloprim (allopurinol), which is still considered the safer alternative. Manufactured by Takeda Pharmaceuticals, Inc., Uloric was prescribed to patients with severe renal dysfunction or, under limited circumstances, individuals who could not be maintained on Zyloprim.
On February 21, 2019, the Food and Drug Administration (FDA) released a Second Drug Safety Communication regarding adverse reactions associated with Uloric use as compared to other gout drugs—such as Zyloprim. The notice included a black box warning that alerted patients of an increased risk of sudden death and life-threatening cardiovascular events.
Considering there are over 8 million individuals in the United States alone that suffer from gout, a drug that could potentially relieve gout-related symptoms is a prized commodity; this is particularly poignant considering that a gout condition is known to at times subside, only to flare up again with no discernible cause.
That said, Uloric does not appear to be the answer for those that are suffering. An FDA trial studied 6,000 patients taking Uloric to treat gout symptoms and found all experienced a higher likelihood of developing the following conditions:
- Heart-related death
- Non-fatal heart attack
- Non-fatal stroke
- An inadequate blood supply to the heart, thereby requiring emergency surgery
These findings provoked the FDA to issue a black box warning—its most severe warning in connection with a pharmaceutical drug. Sadly, for those that are suffering, the FDA did not initiate a full recall of Uloric or its generic equivalent.
Slater Slater Schulman LLP is dedicated to the representation of individuals who have been injured by their ingestion of Uloric. If you or someone you love has been injured as a result of their Uloric use, please contact Slater Slater Schulman LLP for a free consultation by filling out the form on this page or by calling our office at (800) 251-6990.