Uloric is prescribed to treat an arthritic condition known as gout. It was approved by the U.S. Food and Drug Administration (FDA) in 2009.

However, many who take the gout drug Uloric may not be aware that use of this drug is linked to a heightened risk of Uloric heart deaths.

Uloric, generically known as febuxostat, is manufactured by Takeda Pharmaceuticals. Takeda, the largest Japanese and Asian pharmaceutical company, operates its American subsidiary in the Chicago area. It is one of the top 15 pharmaceutical companies in the world. Uloric growth is 17% year over year, adding to Takeda’s profits.

What is Gout?

Gout is a form of arthritis that occurs when there is too much uric acid in the blood. Uric acid crystals form in the blood and the joints which cause swelling, stiffness and intense pain in the joints.

Men seem to be more susceptible to gout than women. In fact, among men, it is the most common form of inflammatory arthritis. It can affect women as well, usually after menopause.

Besides gender, certain risk factors accompany the development of gout. Genetics and age can also affect the development of gout. Lead exposure, diets high in alcohol and meat, and certain medications can also lead to the development of gout.

Uloric Heart Deaths

After the FDA approved Uloric to treat gout, it saw an increase in reports of Uloric heart deaths.

The preclinical trials performed before Uloric was approved connected Uloric use with a higher risk of Uloric heart deaths, heart attacks and strokes. Because of these findings, when Uloric was approved, another study was called for to discover how deeply the drug was connected with heart problems and Uloric heart deaths.

At the end of 2017, this safety study compared Uloric with a different gout medication, allopurinol. Allopurinol is the generic name for Zyloprim and Aloprim.

The results of this Uloric heart deaths safety study showed that while taking Uloric, deaths from heart-related causes were increased. Additionally, deaths from other, non-heart-related causes also increased. Other Uloric side effects were also noted, including non-deadly heart attacks, non-deadly strokes and a dangerous condition known as cardiac ischemia.

This safety study looked at over 6,000 patients who suffered from gout and who took either allopurinol or Uloric.

In November 2017, the FDA sent out a safety communication regarding Uloric heart deaths. They did this as a reaction to the release of the Takeda-sponsored safety study that found the increase in Uloric heart deaths.

The FDA wrote, “The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.”

It went on to say, “The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”

They noted that they are continuing to evaluate the Uloric heart deaths safety issue and will update the public when they receive more information.