Your Uloric Lawsuit: Issues

What is Uloric? Uloric (Febuxostat) is used in the treatment of gout, which is a type of arthritis in which uric acid builds up in the joints, causing sudden swelling, heat, redness and pain in one or more joints. Uric acid is the breakdown product of purines, which are present in many of the foods we eat. When the body is unable to handle the uric acid, the crystallization of the compounds in joints causes these painful attacks. Should the uric acid crystals block the kidney filtering tubules, kidney failure can occur. Interestingly, gout has the dubious distinction of being one of the most frequently recorded medical illnesses throughout history.

The small joint at the base of the big toe tends to be the most common site for an attack of gout, although elbows, fingers, wrists, knees and ankles are also commonly affected joints. Among those who experience gout, the pain can be intense, although the most painful part of the gout attack usually subsides within a few hours to a few days. Rarely, a gout attack will last for weeks. Most of those who experience an attack of gout will continue to have gout attacks throughout their life. 

Uloric is in a class of medications called xanthine oxidase inhibitors; these xanthine oxidase inhibitors decrease the amount of uric acid made in the body, therefore can help prevent gout attacks. The drug is, however, unable to treat the gout attacks once they occur. Uloric comes in tablet form and is usually taken once per day, although it can take months before Uloric starts preventing gout attacks, and, in fact, the number of gout attacks may actually increase during the first six months of treatment.

What are Uloric Side Effects and Potential Injuries? For the estimated three to eight million Americans who experience attacks of gout each year, Uloric could seem like a blessing. Unfortunately, there are significant problems associated with the drug, which was touted as the first new medication approved in more than four decades for the management of elevated levels of uric acid. In fact, Uloric now contains a warning regarding cardiovascular death.

Those taking the drug are advised to seek emergency medical assistance immediately if they experience irregular heartbeat, dizziness, rapid heartrate, fainting, trouble breathing, weakness in one side of the body, sudden blurry vision, sudden slurring of speech or sudden severe headache. Aside from cardiovascular issues, Uloric can cause gout flares (even though the medication is meant to diminish gout symptoms) or can cause liver problems, kidney damage, bone marrow failure or severe skin and allergy issues. Signs of a liver problem include sudden fatigue, pain, aching or tenderness on the right side of the stomach, dark-colored urine, jaundice, or a loss of appetite which lasts several days.

Will there be a Uloric Lawsuit? In 2018, a former safety consultant for Takeda, Dr. Helen Ge, filed a whistleblower Uloric lawsuit against the manufacturer claiming Takeda failed to reveal available risk information about the extremely serious potential Uloric side effects. Ge also asserted that Takeda failed to provide adequate Uloric warnings to consumers and physicians that Uloric could have adverse results when interacting with other drugs and that Takeda claimed cardiovascular Uloric side effects were less severe than they actually were by modifying and altering documents sent to the FDA.

Allegations in Ge’s Uloric lawsuit are that some patients taking Uloric died as a result of this failure to provide adequate Uloric Warnings. Finally, Ge’s whistleblower Uloric lawsuit contended that the actions of Takeda resulted in the Medicare and Medicaid systems being defrauded because the cost of the drug is $5 per day, while the cost for allopurinol, an alternative treatment for gout, costs only 10 cents per day.

Now that Takeda has been forced to place a Uloric Black Boxed Warning on the drug, it is expected that many Uloric lawsuits will be filed by consumers who have experienced severe injury after taking the drug. In particular, if it turns out that Takeda did actually know of the serious dangers of the drug yet downplayed or covered up those dangers in order to obtain FDA approval, the manufacturer could face large numbers of Uloric lawsuits.

Has the FDA mandated and Uloric Warnings? Since 2009, when Uloric received FDA approval, hundreds of thousands of patients in the United States have taken the drug. In November 2017 the FDA issued a drug safety alert which warned those taking Uloric that there was an increased risk of cardiac-related deaths among those taking the drug. At that time, the FDA allowed the drug to remain on the market, contingent on the final results of the drug manufacturer’s post-marketing safety studies. Physicians were warned to consider the potential of an increased risk of cerebrovascular events, heart-related deaths and myocardial infarctions among those taking Uloric.

By the fall of 2018, the FDA announced Takeda had provided the agency with the results of the post-marketing study and that an advisory committee meeting of external experts would be convened to discuss the safety of the drug.  In 2019, after reviewing the data, the FDA required Takeda to implement a Black Boxed Uloric Warning—the most serious, urgent warning the FDA can issue—due to an increased risk of heart-related Uloric deaths. The post-marketing study actually appeared to show an overall increased risk of death for those taking Uloric, not only for cardiovascular issues, but death from any cause.

How Sullo & Sullo Can Help with Your Uloric Lawsuit - Those who have taken Uloric and suffered injury as a result may be considering Uloric lawsuits. If you are considering a Uloric lawsuit, it is important to speak to an experienced Uloric lawyer who can review the facts of your case and let you know whether a Uloric lawsuit is appropriate for you. To speak to a knowledgeable Uloric lawsuit lawyer, contact the Houston law firm of Sullo & Sullo. We can provide you with a Uloric attorney who can answer all your questions regarding a Uloric lawsuit and can also ensure you receive appropriate medical treatment for your Uloric injuries.

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