Uloric and Strokes

Uloric and strokes have been connected to each other by a massive clinical trial, which found that people taking Uloric faced a heightened risk of a fatal cardiovascular event. Unfortunately, the results of this trial were only released a decade after Uloric had been approved to treat gout. Since the release of the clinical trial, the U.S. Food and Drug Administration (FDA) has updated Uloric’s warning label to include the risks of a stroke. Uloric is currently the subject of numerous lawsuits alleging the drug is unsafe and that the manufacturer failed to warn patients of these risks.

• 1. What is Uloric?
• 2. Uloric and strokes
• 3. FDA takes action after clinical trial
• 4. Strokes and their symptoms

1. What is Uloric?

Uloric is a pill-based prescription medication for gout, a type of arthritis that comes from the buildup of uric acid in the joints and tendons. Uloric treats gout over the long-term by cutting down the levels of uric acid in a patient’s bloodstream, preventing the acid from accumulating.

Uloric was originally approved by the FDA in 2009.

Some of the most common side effects of Uloric are:

• Nausea,
• Trouble breathing,
• Dizziness,
• Fatigue,
• Skin rash,
• Numbness in the extremities, and
• Pain and swelling in the joints.

There are, however, more severe side effects that have been associated with Uloric, as well:

• Gout flares,
• Severe allergic reactions, including Stevens-Johnson Syndrome,
• Liver problems, and
• An increased risk for fatal cardiovascular events, including strokes, unstable anginas, and heart attacks.

2. Uloric and strokes

An extensive postmarket clinical trial showed that Uloric carried a higher risk for fatal cardiovascular events, including strokes, and non-heart-related deaths than the alternative long-term gout treatment, Zyloprim.

Even while it was considering Uloric for approval in 2009, the FDA was worried about the potential for Uloric to cause heart problems. When Takeda Pharmaceutical Company, Uloric’s manufacturer in the United States, requested the FDA approve Uloric in 80 milligram and 120 milligram doses, the FDA balked. Citing its concern that Uloric could cause cardiovascular events, the FDA only approved the drug in 40 and 80 milligram doses.¹

The FDA also included the potential risk for heart problems like strokes on Uloric’s original warning label before approving the drug for use in the U.S.²

Finally, the FDA required Takeda to perform a postmarket clinical trial, to be completed by 2015, to see if Uloric posed a cardiovascular risk to those taking it.³

The results of postmarket clinical trial, called the CARES trial, were not released until 2018.⁴ The trial followed nearly 3,100 people who were taking Uloric to treat their gout, and another 3,100 people taking Zyloprim for their gout. The trial monitored the participants for seven years to compare how often each group would suffer any of the following cardiovascular events:

• Nonfatal strokes,
• Nonfatal heart attacks,
• Nonfatal unstable anginas,
• Any type of fatal cardiovascular death, or
• Any type of non-cardiovascular death.

The CARES trial showed that nonfatal strokes were suffered at the same rate by people taking Uloric and Zyloprim. However, the risks of suffering a fatal cardiovascular event or non-heart-related death were significantly higher for Uloric patients:⁵

3. FDA takes action after clinical trial

After the results of the CARES trial were released, the FDA issued a safety announcement about the drug’s increased risks of causing cardiovascular problems, and added a box warning to Uloric’s label.

The box warning on Uloric’s updated warning label contained a notice for doctors and patients about the risks of fatal strokes and other cardiovascular deaths that came from taking Uloric.⁶ Boxed warnings like these are the FDA’s strongest statements about the dangers of a prescription drug.

The FDA’s safety announcement alerted people taking Uloric to be wary of the symptoms of a stroke, including:

• Numbness or weakness, especially if it is contained to only one side of your body,
• A sudden and severe headache, and
• Unexpected speech problems.⁷

The safety announcement also included information about the FDA’s narrowed list of approved uses for Uloric: The agency now only approved Uloric for patients who had tried Zyloprim, but had either suffered a side effect of the drug or were not responding well to it.⁸

4. Strokes and their symptoms

A stroke is the loss of blood flow to the brain. The brain damage that this can cause is significant enough that half of the people who suffer a stroke live for less than a year afterwards.⁹

The symptoms of a stroke depend on the part of the brain that loses blood flow. Common symptoms include:

• Headache,
• Confusion,
• Numbness,
• Changes to sensory perception, like taste, smell, hearing, or vision,
• Muscular weakness in the face, including the tongue,
• Balance problems,
• Memory problems, and
• Vomiting.

Victims of strokes caused by Uloric may have a legal right to compensation, especially if the stroke proved to be a fatal one. Numerous Uloric lawsuits have been filed against Takeda for failing to warn doctors and patients of the risks of a stroke. These lawsuits seek compensation for:

• Medical expenses,
• Reduced earning capacity,
• Wages lost,
• Pain and suffering, and
• The loss of companionship suffered by the victim’s family.

Where the stroke was a fatal one, these lawsuits are wrongful death claims brought by the victim’s family.

Legal References:

1. FDA Approval Letter for Uloric – 2009.
2. FDA Warning Label for Uloric – 2009.
3. See note 1.
4. Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities.
5. See note 4. See also Choi H, Neogi T, Stamp L, Dalbeth N, Terkeltaub R, “New Perspectives in Rheumatology: Implications of the Cardiovascular Safety of Febuxostat and Allopurinol in Patients With Gout and Cardiovascular Morbidities Trial and the Associated Food and Drug Administration Public Safety Alert,” Arthritis Rheumatology 70(11):1702-9 (November 2018).
6. FDA Warning Label for Uloric – 2019.
7. FDA Drug Safety Communication, “FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat),” (February 21, 2019).
8. See note 7.
9. Donnan GA, Fisher M, Macleod M, Davis SM, “Stroke,” The Lancet 371(9624):1612-23 (May 10, 2008).