Uloric Lawsuit Claims Heart Problems Make Gout Drug Dangerously Defective

A Texas man indicates that he suffered a cardiac arrest due to side effects of Uloric, alleging in a recently filed product liability lawsuit that the gout drug is “dangerously defective”.

Michael Hall filed the complaint (PDF) against Takeda Pharmaceuticals earlier this month in the U.S. District Court for the Northern District of Illinois, accusing the manufacturer of failing to warn patients and the medical community about the risk of serious health problems linked to Uloric.

According to the lawsuit, Hall was prescribed Uloric by his doctor in 2010, for the treatment of gout. In June 2018, he suffered a cardiac arrest, which the lawsuit blames on side effects of the medication, indicating that the health risks and interactions with other drugs constitute a design defect that the drug maker knew or should have known about.

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

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

In February 2019, the FDA announced that 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 heart problems, which was not adequately reflected by the drug maker in the past.

Part of the problem, according to the lawsuit, was a failure of manufacturers to test or warn about the risk of interactions with drugs commonly taken by the same patient population.

“Defendants suppressed knowledge of and failed to submit full and complete Periodic Adverse Drug Experience Reports to FDA, which would have shown that there were increased risks from Uloric associated with Drug/Drug Interaction while treating gout,” the lawsuit states. “Such conduct by Defendants deviated from the duties and conduct of a responsible pharmaceutical manufacturer and demonstrated a failure to ensure its own minimal compliance with requirements of the Federal Food Drug and Cosmetic Act.”

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.

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.

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