A North Carolina man who took Uloric (febuxostat) for gout and suffered cardiac side effectshas filed a lawsuit against the drug’s manufacturers, Takeda Pharmaceuticals USA Inc. and Takeda Pharmaceuticals America Inc.

According to the complaint, plaintiff Shelley O’s physician prescribed Uloric in 2012 for the treatment of gout, believing the medication to be a safe choice.

Nearly four years later, in November 2016, Shelley suffered severe chest pain and was diagnosed with unstable angina and coronary artery disease affecting multiple vessels. The situation required emergency  surgery that involved bypass grafting. Shelley claims he experienced worsening coronary artery disease and ischemic endangerment that required ongoing medical observation, conditions he blames on taking Uloric for gout.

What is Gout?

Hyperuricemia, commonly known as gout, refers to a form of inflammatory arthritis  in which there is excess uric acid in the blood. The acid forms “needle-like crystals in a joint and cause sudden, severe episodes of pain, tenderness, redness, warmth and swelling,” according to the Arthritis Foundation.

Too much uric acid in the bloodstream can lead to gout. Normally, excess uric acid is eliminated from the body through urine, but there are reasons and conditions why it may not.

People at risk for gout are those who consume diets high in foods with purine, or those who may have kidney disease, diabetes, or cancer, and undergoing chemotherapy. It’s possible to have asymptomatic hyperuricemia for years before developing painful gout in which one or more joints become inflamed due to the deposits of uric acid crystals in the tissues.

According to Shelley’s lawsuit, Takeda failed to comply with reporting requirements associated with the approval of its new drug in 2009. As part of the approval, Takeda was to submit, on a regular basis, adverse event reports to the U.S. Food and Drug Administration (FDA). Takeda purportedly not only failed to do so, but also tried submitting false reports.

There were already concerns regarding how Uloric possibly increased the risk of cardiac events compared to its competitor, Allopurinol. Because of these concerns, the FDA requested additional data from Takeda. Because the data was difficult to draw conclusions from, the drug was approved with the condition that a post-market study be started in 2010 and completed by 2014.

The Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout, known as the CARES trial, did not finish until several years outside of the FDA-established timeline. The post-market study results were released in the New England Journal of Medicine in spring 2018, and the data concluded that mortality for all reasons, and cardiovascular mortality in particular, was greater with Uloric than Allopurinol.

The FDA responded by requiring a black box warning be added to the drug’s label. The warning was added in February 2019, 10 years after Uloric’s approval and, according to NEJM Journal Watch, clearly warns medical care clinicians and patients of the increased risk of dying from a cardiovascular event while taking the medication.

The complainant is seeking damages for the injuries he suffered along with the emotional toll these injuries took.