Lawsuit Filed Over Stroke Caused By Uloric Side Effects

Manufacturers of the gout drug Uloric face a product liability lawsuit filed by a Georgia man, who alleges users and the medical community were not adequately warned about the risk of major heart problems and strokes.

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 that suggest users may be more likely to experience severe cardiovascular problems, leading the FDA to require new warnings about the Uloric side effects in 2019.

As a result of the failure to provide earlier warnings and information about the risks, a number of Uloric lawsuits are now being pursued by former users, alleging that they may have avoided a heart attack, stroke or other injuries by using a different treatment for gout.

In a complaint (PDF) filed last month in the U.S. District Court for the Northern District of Illinois, Kenneth Sellers indicates he suffered a cerebrovascular accident, more commonly known as a stroke, shortly before new warnings were added to the medication.

According to the lawsuit, Sellers was prescribed Uloric for treatment of his medically diagnosed gout in July 2018, suffering stroke in February 2019, which resulted in the need for medical treatment that has left him with a permanent injury.

The same month that Sellers was injured, the FDA required the drug maker to add the strongest label warning possible for a prescription medication, requiring a  Uloric “black box” warning about the risk of cardiovascular side effects, which was not adequately reflected by the drug maker in the past.

“Defendants did not timely or adequately apprise the public and physicians, including Plaintiff’s physicians, of the adverse effect or defects in Uloric despite Defendants’ knowledge that it had failed due to the described defects,” Sellers’ lawsuit states. “As a result of Defendants’ actions, Plaintiff and his physicians were unaware, and could not have reasonably known or have learned through reasonable diligence that Plaintiff would be exposed to the risks identified in this Complaint and that those risks were the direct and proximate result of Defendants’ conduct.”

Although some critics have called for a Uloric recall to be issued due to the heart risks, the medications has remained on the market, with severe limitations on its approved uses. However, sellers and other plaintiffs allege that they may have avoided severe and life-altering injuries if earlier warnings and information had been disclosed by the drug makers.