Uloric is a medication prescribed to manage and treat chronic gout, which is a type of inflammatory arthritis. Inflammation occurs as the result of excess uric acid in the blood, which forms needle-like crystals in the joints. The formation of these crystals results in sudden, sever episodes of pain, swelling, and warmth.
The FDA approved Uloric (febuxostat) FDA in 2009 for the treatment of gout in adults. The medication has been successful in lowering uric acid levels in the blood, it has also been linked to cardiovascular events. The drug-maker Takeda Pharmaceuticals was ordered to conduct a safety trial after the medications release. The trial results, published in the New England Journal of Medicine, showed a higher risk of cardiovascular death for patients taking Uloric compared to those taking allopurinol, an alternative gout medication.
In February of 2019, the FDA ordered the medication’s manufacturer to place a “black box warning” on the medication’s label. A black box warning is the most critical warning the FDA will require, which gets its name from the required black box border that surrounds the warning itself.
The black box warning required disclosure of an increased risk of death when using Uloric as compared to other gout medications. Notwithstanding the results of the clinical trial and this warning, Uloric is still on the market and regularly prescribed to patients.
A whistleblower lawsuit was filed alleging that Takeda Pharmaceuticals knew about the increased danger of cardiovascular events when taking Uloric, yet concealed them from the public. The complaint alleges the manufacturer altered documents sent to the FDA when seeking approval. The lawsuit was ultimately dismissed for technical reasons; however, the dismissal was opposed by the U.S. Department of Justice on public policy grounds.
If you or a loved one has suffered a serious cardiovascular event while taking Uloric, contact the experienced product liability attorneys at Neumann Law Group for a free consultation.