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Uloric Gout Drug FDA Warning Prompts New Lawsuits

Danger Linked to Uloric Gout Medication and New Litigation

In February 2019 the United States Food and Drug Administration began limiting the use of the drug known as Uloric and required new warnings be placed on the label after a study revealed that the drug came with an increased risk of heart-related death.

Uloric, also known as febuxostat, was approved by the FDA in 2009 to treat gout which is a type of arthritis in adults. Uloric treated arthritis by lowering uric acid levels in the blood. When uric acid levels in the blood are elevated, a person can experience symptoms of pain, swelling, and redness all commonly considered symptoms of gout.

In addition to the FDA’s efforts to ensure that Uloric now is properly labeled with a warning of the possible health risks and negative effects found in a recent study, they are also limiting its usage by only allowing patients to receive an Uloric prescription after they have not had effective results after using alternative gout medications or if they suffer negative side effects from these alternative medications. The most notable of these alternative prescriptions is allopurinol, also known as Zyloprim.

Clinical Survey Conclusions Regarding Uloric Safety

As a condition of Uloric’s approval by the FDA in 2009, Uloric’s manufacturer, Takeda Pharmaceuticals, was charged with conducting a clinical trial of the drug on more than 6,000 patients in order to further determine the level of already known possible risk for heart issues taking it caused. As a result of these clinical trials, scientists discovered that among those that took Uloric to treat gout, there was an increased risk of heart-related deaths and deaths from all causes. In patients treated with Uloric, the clinical trials found that there were 15 deaths from heart-related causes for every 1,000 patients treated for a year. There were also 26 deaths from any cause per 1,000 treated with Uloric.

Product Liability Lawsuits over Dangerous Medication

As a result of the recent revelations regarding Uloric’s increased risk for causing injury, many people that have relied on this medication to treat their gout and suffered, are considering taking legal action. Those that have been injured by a product that was either defective, improperly labeled, or improperly marketed in a way that would cause consumer harm can file a product liability lawsuit. Parties such as the manufacturer, the distributor, or healthcare providers in the case of medication can be considered liable for damages caused by dangerous products.

In the event that someone suffers an injury after using Uloric, it is imperative that they first get the medical attention that they need and then speak to an attorney experienced in handling cases involving an injury caused by dangerous medications. These injuries can inflict severe damages that can derail someone’s entire life but an attorney can assist you in trying to get a piece back through a lawsuit and help ensure it doesn’t happen to someone else. There are currently thousands of people across the country that are reporting injuries that they believe were caused by Uloric use or at least contributed towards by their use of the drug.

Whistleblower Lawsuits against Takeda Pharmaceuticals over Uloric

An initial whistleblower lawsuit was filed by Takeda pharmaceutical’s former safety consultant Dr. Helen Ge. The lawsuit filed by Dr. Ge claims that Takeda pharmaceuticals did not reveal available risk information about Uloric and its possible serious side effects which include health issues such as liver problems, kidney damage, and bone marrow failure. The lawsuit also claims that Takeda Pharmaceuticals failed to inform the consumers and public that the drug could interact with other medications producing negative results.

Additional claims also include allegations that Takeda made the harmful cardiac side effects of Uloric use less severe than they really are by modifying documents sent to the FDA. This failure to disclose important information regarding the side effects of Uloric use to the FDA allegedly resulted in the death of some patients taking the drug.

Finally, the lawsuit alleges that Takeda Pharmaceuticals defrauded Medicare and Medicaid based on the fact that Uloric costs 5 dollars per day while its alternative, allopurinol costs only 10 cents per day.

Injuries Caused by Uloric

People that have taken Uloric to combat the symptoms of gout should be on the lookout for the following symptoms that may indicate an issue caused by Uloric use.

  • Rapid or irregular heart rate
  • Chest pains, especially in the heart region
  • Breathing problems
  • Difficulty talking or forming sentences
  • Numbness or weakness affecting one side of the body
  • Severe headaches
  • Dizziness, vertigo, or trouble maintaining balance

All of these symptoms are typically related to cardiovascular health issues that can severely injure or even kill those that have used Uloric. If you experience any of these symptoms it is imperative that you seek medical assistance as soon as possible. People that have taken Uloric to combat gout are at an especially high risk to suffer from the following health issues.

  • Heart Attack (non-fatal)
  • Stroke (non-fatal)
  • Heart-Related Death
  • Unstable Angina
  • Death caused by above or similar situations, not related to heart

Seek an Experienced Florida Product Liability Attorney

If you or a loved one have suffered from any of the aforementioned conditions and have taken Uloric medication in the past, then do not hesitate to contact Dolman Law Group for a free consultation. Our skilled lawyers have experience in assisting in drug injury claims and getting clients the compensation that they deserve. We are more than happy to hear the details of your case and advise you on what kind of legal options are available to you. 

Dolman Law Group is a Clearwater-based serious injury and civil trial law firm. Our injury law attorneys have represented a long list of individuals who have suffered critical and/or fatal injuries. It is our steadfast goal to prosecute those responsible for releasing these hazardous medications while knowing their dangers. When you hire Dolman Law Group you are hiring a firm that will give you the personal attention one would expect from a smaller firm with big firm results.

Contact us today at 727-451-6900 or fill out a contact form online for a free and confidential consultation on your case.

Dolman Law Group
800 North Belcher Road
Clearwater, FL 33765
727-451-6900

Uloric Gout Lawsuit Attorneys