If you or someone you know has suffered from severe adverse side effects and complications while taking the gout medication Uloric, you may be eligible to file a Uloric lawsuit to recover medical expenses and other damages.

An announcement was recently made by the U.S. Food and Drug Administration (FDA) advising the public about heart-related side effects linked to Uloric. The announcement was based on results from a preliminary study that found Uloric patients had a higher incidence of heart attacks and other adverse side effects including cardiac ischemia.

A cardiac or myocardial ischemia results from deceased blood flow to the heart. Major blood vessel damage or disease may lead to cardiac ischemia developments that include symptoms such as shortness of breath when physically active, fatigue, shoulder to arm pain, sweating, nausea and vomiting, and neck or jaw pain.

The FDA announcement was released after the drug’s manufacturer, Takeda Pharmaceuticals, released the results of the study. The study compared Uloric to allopurinol, another gout medication, sold under brand names Zylorprim and Aloprim.

Overview: Filing a Uloric Lawsuit

Two Drug Safety Communications were released by the FDA on Nov. 15, 2017, advising of Uloric’s increased risks for heart attacks. According to the FDA’s announcement, “preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”

The FDA first approved Uloric in 2009 for the treatment of gout. Gout is a condition which occurs with excess build- up of uric acid. Gout symptom attacks can include symptoms of redness, swelling, and pain. As a medication, Ulroic, helps decrease bloodstream uric acid levels.

The FDA’s announcement also recommended that “[h]ealth care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”

The preliminary trial or CARES trial that began in 2010 and continued for seven years, evaluated more than 6,000 patients with gout conditions across the United States and across 320 centers. During the CARES trial, not only patients with gout were evaluated. Some patients had conditions ranging from peripheral arterial disease, stroke, heart attack, diabetes, small vessel disease, and unstable angina.

The CARES trial included patients that were randomly assigned one of two gout medications, Uloric or allopurinol. Medical health outcomes of the patients were tracked between a span of 2.5 and 6.5 years. However, what was highlighted by the researchers was that for patients assigned Uloric, 45 percent of them discontinued the trial due to adverse side effects. The study was published in the New England Journal of Medicine.

A Uloric lawsuit was first filed by a whistleblower and former Takeda safety consultant in 2012 over allegations that the company hid pertinent information regarding Uloric’s adverse side effects from the government. The lawsuit accused Takeda of failing to inform regulators and the public of Uloric’s potential complications when taken with other medications such as metahadone, warfarin, imuran, and digoxin. Allegations purported also included that Uloric could potentially cause bone marrow failure, severe bleeding, and kidney failure.