Uloric, also known as febuxostat, is a prescriptive drug used to treat gout, a type of uncomfortable and painful arthritis found in adults. Gout occurs when too much uric acid builds up in the body and the body cannot adequately dispose of it. The build up of uric acid then causes inflammation, swelling, and the destruction of cartilage and bone. Patients with gout typically experience a build up of xanthine oxidase, an enzyme that gets converted to uric acid. Doctors prescribe Uloric because it inhibits xanthine oxidase (XO) and lowers XO numbers in the body, therefore helping with the chronic management of hyperuricemia in patients with gout.
Manufactured by Takeda Pharmaceuticals
, the FDA approved Uloric in February 2009 to lower uric acid levels in a patient’s blood. Following its release, the gout drug quickly became a popular medication among consumers to relieve their discomfort. Over 1 million prescriptions for Uloric get prescribed annually. This makes Uloric one of Takeda Pharmaceuticals more lucrative drugs. In fact, Uloric costs more than other gout drugs on the market, costing $353 per prescription.
However, the FDA rejected Uloric's New Drug Application (NDA) application twice before the tentative 2009 approval. The FDA expressed initial concerns with the product's ability to cause Major Adverse Cardiac Events (MACE). When Uloric was approved, the FDA made the drug go through a post-marketing study to provide additional information about possible risks, benefits, and best uses for the drug. The trials revealed potentially deadly consequences of taking the popular gout medication.
In 2012, previous Takeda Pharmaceuticals safety consultant, Helen Ge, filed a whistleblower lawsuit against Takeda Pharmaceuticals. Ge alleged that by not reporting the dangerous side effects of Uloric when using it in combination with additional drugs, Takeda Pharmaceuticals defrauded both Medicaid and Medicare.
If Ge's claim is proven to be true, Takeda Pharmaceuticals could find themselves liable for knowingly selling a dangerous pharmaceutical drug without adequately informing consumers about its dangerous and potentially lethal side effects.