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Uloric Gout Medication Linked to Increased Risk of Heart-Related Deaths

Earlier this year, the United States Food and Drug Administration (FDA) issued a release announcing their concerns about Uloric, a medication used to treat gout. Studies show that Uloric raises the risk of a patient’s death by heart-related issues, along with a general overall increased risk of death, when compared to the alternative medication, Allopurinol.

Uloric History

Prior to FDA approval in 2009, clinical trials were conducted, and the results showed that patients on Uloric suffered more heart-related issues when compared to those patients taking Allopurinol. Therefore, Uloric should have been required to contain warnings about cardiovascular risks once the FDA approved the drug. However, there are allegations that the parent company, Takeda Pharmaceutical Company Ltd., modified the submitted FDA documents. The end result was a failure to properly disclose all potential side effects of Uloric, and some patients died while on the medication.

Uloric is also known by its generic name, febuxostat. The increased cardiovascular risk from the drug can lead to cardiac arrest or even death. Heart-related risks can include non-deadly heart attacks, fatal heart attacks, stroke, cardiac ischemia that requires emergency surgery, and more. In the clinic trials, it was determined that out of every 1,000 patients, 15 experienced heart-related side effects. It is estimated that out of 1,000 users, about 26 users died in a one-year period.

After the FDA completed a new study in 2018 to compare the side effects of the two gout medications, they concluded that Uloric was linked to a higher risk of cardiovascular disease. Because of this, the FDA added a Black Box warning. There is a chance they could issue a recall at some point and remove the drug from the market entirely.

Symptoms and Side Effects of Uloric

If you are on Uloric and any of the following symptoms appear, you need to see a medical professional:

  • Difficulty with speech
  • Shortness of breath
  • Sudden and severe headache
  • Chest pain
  • Irregular or rapid heartbeat
  • Dizziness
  • Weakness or numbness on one side of the body

There are also other serious side effects of Uloric, which can include:

  • Liver failure
  • Numbness in extremities
  • Liver enzyme abnormalities
  • Kidney failure

Kidney issues have been becoming more common, and that prompted Takeda to include dosing recommendations in 2017, which limits the drug intake to 40 mg per day.

What is the Potential for a Lawsuit?

In situations like this, there may be multiple avenues for litigation. You might be able to pursue a claim for negligence based on their failure to properly disclose the potential side effects and health risks. However, there is also another potential avenue for litigation here. This involves a potential design flaw. The argument could be made that Uloric’s risk of heart-related death was actually a design flaw. It means the drug was manufactured properly, but it is still inherently dangerous to anyone taking it.

Contact a Maryland Personal Injury Attorney

If you have suffered injuries due to Uloric, it is important you speak to a Maryland personal injury attorney who can advise you of your legal options. Contact the Law Office of Robert R. Castro today at 301-870-1200 today to schedule an initial consultation. Let us evaluate your case and advise you on how you might receive compensation for your pain and suffering.

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