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Uloric Black Box Warning


The FDA issued a black box warning for the gout medication Uloric (febuxostat) in February 2019 after results of a clinical safety study found an increased risk of heart-related death and death from all causes compared to other drugs to treat gout. Uloric lawsuits claim that Takeda, the manufacturer of Uloric, failed to warn users of the increased risk of heart attacks and strokes.

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Uloric and the FDA Black Box Warning

Uloric was approved in 2009 to treat gout in adults. At that time, the FDA included a Warning and Precaution in the Uloric prescribing information to indicate possible drug side effects, namely cardiovascular problems. And a condition of approval was that the drug manufacturer, Takeda Pharmaceuticals America, Inc.conduct an extensive post-market safety clinical trial, which was called Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Comorbidities (CARES) trial. The results of the 6,000-patient safety trial were published in the New England Journal of Medicine on March 12, 2018.

Based on a preliminary analysis of CARES, the FDA issued a safety communication in November 2017. Six months later, The Public Citizen consumer advocacy group petitioned that Uloric be recalled. In the June 2018 petition, Michael A. Carome, MD, director of its health research group, urged the FDA to remove the Uloric from the market.

“If such action is not taken, the agency should require the addition of a black box warning about the increased risk of cardiovascular death and modify the approved indication to limit use of the drug to patients who are not able to use allopurinol,” he told Healio Rheumatology.

By January 2019, Uloric had been linked to more heart-related deaths than was allopurinol, the drug typically given to patients with gout and cardiovascular disease.

The FDA ordered a black box warning in February 2019 for Uloric and restricted its approved uses to patients who cannot tolerate allopurinol (Zyloprim and Aloprim) for various reasons. Clinicians have been advised to educate patients about the cardiovascular risks of Uloric, and tell patients to seek medical attention right away if they experience symptoms like chest pain, shortness of breath, and irregular heartbeat while taking the gout drug.

Uloric and Gout

Gout is a painful form of arthritis caused by an excess of a naturally occurring substance called uric acid in the body that causes sudden attacks of redness, swelling, and pain in one or more joints, commonly in the feet and toes.

Uloric, a xanthine oxidase inhibitor prescribed for the chronic management of excess uric acid, works by lowering uric acid levels in the blood. Uric acid passes through the liver, and enters your bloodstream. Most of it is excreted in your urine, or passes through your intestines to regulate "normal" levels.

A study conducted in 2013 associated excess uric acid (hyperuricemia) with cardiovascular issues. It suggested that febuxostat (Uloric) was well tolerated, with drug side effects similar to allopurinol. Adverse effects were generally considered to be mild to moderate. “However, clinical practice still needs further clinical trials finalized to assess urate-lowering efficacy in the much more global context of renal and cardiovascular prevention… Safety and cost/benefit will also need further investigation in this specific field, especially regarding these new therapeutic strategies,” the researchers concluded. (Allopurino is much less expensive than Uloric.)

Who is at Risk

The risk of heart-related events in patients with hyperuricemia and gout is not fully understood but it may be related to chronic inflammation associated with the underlying disease process.

Considering the growth of the ageing population, the incidence and prevalence of gout in the elderly is increasing. This chronic disease affects approximately 8.3 million adults in the U.S. If you or a loved one have experienced the following serious heart problems and have been prescribed Uloric, you may be entitled to compensation.

  • Heart Attack
  • Stroke
  • Pulmonary Embolism (PE)
  • Deep-Vein Thrombosis (DVT)
  • Angina
  • Heart-Related Death

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