Does Uloric Cause Heart Problems?

In early 2019, the Food and Drug Administration (FDA) publicly announced that the gout medication Uloric (with the active ingredient febuxostat) carries an increased risk of heart-related and overall deaths when compared with a similar gout medication called allopurinol.

Based on these findings, the FDA has issued a black box warning – the most serious advisory issued by the agency.

These findings raise many troubling questions, especially when we consider the fact that Uloric has been on the market for over a decade.

Let’s take a deeper look at the scientific studies which have established a link between the use of Uloric and an increased risk of heart attacks.

Findings of the CARES Trial

This FDA warning is primarily based on the findings of a study called the CARES Trial – which is short for the Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities.

This study was carried out in 2010, shortly after Uloric was approved for release to the public. The FDA required the manufacturer of the drug, Takeda Pharmaceuticals, to conduct this study in order to determine how well the drug would work when given to patients with gout.

The CARES Trial was a double-blind study which analyzed the effects of both Uloric and allopurinol. 6,200 participants were involved, with half taking Uloric and the other half taking the competing gout drug allopurinol.

Originally slated to last over a nine-year period, the study was cut short in 2017 after researchers determined that Uloric likely carried a heightened risk of heart-related problems when compared to allopurinol. In November of 2017, the FDA officially alerted the public that Uloric had an increased risk of cardiovascular death when compared to allopurinol.

In the end, this study is what resulted in the issuance of a black box warning for Uloric. The FDA also told healthcare professionals that they should only prescribe Uloric to patients who have either tried allopurinol without success or who had extreme side effects from allopurinol.

CASE Study Results by the Numbers

Here is a look at the breakdown of the CARES Trial study results:

Heart Attack Deaths – Uloric vs. Allopurinol
  • Uloric Deaths by Heart Attacks: 15 in 1,000 patients
  • Allopurinol Deaths by Heart Attacks: 11 in 1,000 patients
All Deaths – Uloric vs. Allopurinol
  • Uloric Deaths by Any Cause: 26 in 1,000 patients
  • Allopurinol Deaths by Any Cause: 22 in 1,000

As you can see, the CARES Trial showed that Uloric users had a greater chance of both cardiovascular deaths and deaths in all categories when compared to users of allopurinol.

Legal Options For People Affected by Uloric-Related Heart Attacks

The findings of these studies beg the question of whether Takeda Pharmaceuticals unnecessarily placed Uloric patients in danger.

Since these findings have been released, there has been a growing interest in taking legal action against Takeda. Patients who have suffered heart attacks, and the families of those who have died from cardiovascular problems while taking Uloric, are exploring their legal options against the pharmaceutical company. At least one lawsuit has already been filed in Illinois.

If you or someone you love has suffered a heart attack while taking Uloric, we understand the difficulties your family is facing. You can learn more about your legal options, including a potential lawsuit against Uloric, by contacting one of our experienced defective drug attorneys.