Uloric Cardiovascular Side Effects Results in Lawsuit Against Makers of Gout Drug

A Kentucky man indicates cardiovascular side effects of Uloric caused him to develop congestive heart failure following use of the gout drug, leaving him with permanent health problems.

The complaint (PDF) was filed by James Wagers in the U.S. District Court for the Northern District of Illinois on August 26, accusing Takeda Pharmaceuticals of failing to adequately warn users and the medical community about the heart risks associated with Uloric.

Wagers indicates he was prescribed Uloric in 2016, for treatment of his gout condition. However, in February 2017 he suffered a heart attack which resulted in the need for medical treatment and left him with on-going complications.

Uloric (febuxostat) was introduced by Takeda Pharmaceuticals in 2009, as a prescription medication intended to lower the blood uric levels among adults diagnosed with gout.

Amid aggressive marketing, the drug rapidly became a blockbuster treatment over the past 10 years. However, growing evidence has emerged in recent years which established a link between Uloric and cardiovascular problems, leading the FDA to require new heart warnings last year.

In February 2019, the FDA announced the drug must carry the strongest label warning the agency can require a drug maker to place on their product, adding a Uloric “black box” warning about the risk of cardiovascular side effects, which was not adequately reflected by the drug maker in the past.

While there were some signs of potential heart risks with Uloric when the drug was first released, it appears the FDA did not understand the true scope of the problems until Takeda released the results of a post-marketing clinical trial. However, growing evidence now suggests Takeda knew or should have known about the Uloric heart attack risks well before then, yet continued to market the drug without adequate warnings.

“Throughout the time Uloric is marketed, Defendants withheld material adverse events

from the public, medical community and FDA,” the lawsuit states. “These include, but were not limited to, unlabeled fatal and life-threatening adverse reactions Defendants knew occurred when a person used Uloric in combination with other drugs commonly used by the same patient population.”

Although some critics have called for a Uloric recall to be issued, the FDA decided to allow the drug to remain on the market, with severe limitations on its approved uses.

Wagers’ case is one of a growing number of Uloric lawsuits being pursued by individuals throughout the U.S., each raising similar allegations that strokes and other heart problems may have been avoided if Takeda had provided earlier warnings about the risks associated with the gout treatment.