Lawsuit Over Uloric Heart Problems Alleges Takeda Failed To Adequately Warn About Risks

Takeda Pharmaceuticals faces a product liability lawsuit over its failure to warn about the heart side effects of Uloric, which also alleges that the gout medication caused a North Carolina man to suffer a heart attack.

The complaint (PDF) was filed by Charles Watson earlier this month in the U.S. District Court for the Northern District of Illinois, indicating that Takeda Pharmaceuticals knew or should have known about the potential for Uloric heart problems, yet failed to adequately warn consumers or the medical community.

Watson was prescribed Uloric for treatment of gout in December 2013, and indicates that he suffered a myocardial infarction in March 2017, which is more commonly known as a heart attack. The lawsuit indicates taking Urloric was the cause of his heart attack, but the drug maker withheld information about known problems and adverse events associated with use of the medication.

Uloric (febuxostat) was introduced by Takeda Pharmaceuticals in 2009, and is designed 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.

While there were some signs of potential cardiac 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 suggests Takeda knew or should have known about the risks well before then, yet continued to market the drug without adequate warnings.

“Defendants suppressed knowledge of, and failed to submit full and complete Periodic Adverse Drug Experience Reports to FDA, which evidenced…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.”

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

This complaint joins a growing number of other Uloric lawsuits filed by individuals throughout the U.S., which suggest if Takeda had provided earlier warnings, many consumers may have avoided suffering a heart attack, stroke or wrongful death by using other gout treatments.