Gout is an extremely painful and common form of inflammatory arthritis. People experience gout when the body produces too much uric acid, which can crystallize and deposit in the joints. The severe pain and swelling in the joints can come on suddenly, and some patients suffer from chronic gout attacks. While doctors recommend dietary changes to treat chronic gout, some patients may require medication to remedy the issue. One such medication to help patients with gout is known as Uloric. However, patients have reported adverse health effects after taking the gout medication. Did you or a loved one experience an injury after taking the gout medication Uloric? Reach out to The Lake Law Firm today to learn more about how a Uloric lawsuit can help you.
Our law firm is currently handling lawsuits on behalf of individuals who suffered injuries or died after taking Uloric to treat gout. Lawsuits against manufacturers of Uloric claim there is an increased risk of heart-related death and death in general while receiving Uloric.
Gout is a chronic ailment that affects over 8 million adults in the United States. The FDA approved Uloric in 2009 to treat hyperuricemia in adults afflicted with gout. Hyperuricemia is elevated levels of uric acid in the body, usually caused by a purine-rich diet. Foods with high amounts of purine include alcohol, meats, and seafood. Uloric is the first prescription medication to receive FDA approval to treat hyperuricemia in 40 years. After FDA approval, Uloric became a widely used and popular treatment for gout.
Gout is a form of arthritis characterized by severe bouts of pain and swelling in the joints, usually the big toe. This occurs when uric acid accumulates and causes attacks in the body. Uloric reduces the amount of uric acid in the body by stopping the body from converting purines into uric acid. It is a small green tablet that patients can take once a day. Typically, patients begin with 40 mg tablets, but doctors may prescribe the maximum dosage of 80mg for some.
In its approval letter in 2009, the FDA stated that clinical trials signaled a higher rate of serious cardiovascular risks in Uloric patients. These cardiovascular problems included cardiac deaths, myocardial infarctions, and strokes. Therefore, the FDA stipulated that Takeda Pharmaceuticals must perform clinical trials and submit the data by 2015 to accurately assess Uloric risks. The clinical trials began in 2010 and compared Uloric patients with those taking the competing gout medication, Zyloprim (allopurinol). Although the FDA letter asked Takeda to submit results in 2015, the company did not release the outcomes of the clinical trial until 2017. This trial showed a significantly greater risk of cardiovascular death in Uloric patients.
Following the results of the clinical trials, the FDA issued a warning announcement and updated Uloric’s labeling in 2019. The FDA concluded that Uloric presents an increased risk of death and mandated a black box warning to notify patients of the risk of cardiovascular complications and death. The FDA also recommended that patients only use Uloric if they could not tolerate the alternative drug, allopurinol.
Despite these concerning potential cardiovascular issues, Takeda Pharmaceuticals has not recalled Uloric at this time.
Uloric carries the risk of serious cardiovascular injury or death. Clinical data has linked Uloric to adverse cardiovascular events. Signs of Uloric cardiovascular complications include:
Uloric patients may suffer severe cardiovascular complications such as heart attacks and strokes. Patients with a history of cardiovascular problems should consider alternative medications to treat their gout.
In 2019, the FDA alerted consumers that there is an increased risk of death while taking Uloric compared to allopurinol, an alternative gout treatment. A former Takeda contractor filed a whistleblower lawsuit against the manufacturer of Uloric in 2011 that claimed Takeda concealed serious side effects of the medication. The lawsuit also alleged that Takeda did not submit adverse health reports to the FDA, and Uloric also caused kidney problems in some patients. The FDA did not update its labeling requirements to warn of these side effects until 2019. Millions of patients took Uloric for nearly 10 years before it contained warnings of heart-related deaths.
If you or a loved one suffered health complications after taking Uloric, you may recover compensation for any or all of the following:
Lawsuits allege that Takeda Pharmaceuticals withheld the potential severe cardiovascular issues associated with Uloric. Despite the availability of safer gout medications such as allopurinol, claimants argue that Takeda continued to distribute Uloric without adequate labeling for years. Had patients known of the cardiovascular events linked to Uloric, they may have chosen an alternative gout treatment. At The Lake Law Firm, we believe that the public is entitled to the full truth regarding the drugs, products, or devices they use. Our helpful and friendly team of lawyers is on standby to speak with you about your potential Uloric lawsuit.
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 525-3529 or submit an inquiry on this page.
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