Takeda Pharmaceuticals faces a product liability filed by a Kentucky man, who indicates he suffered a heart attack caused by Uloric side effects, alleging the manufacturer of the gout medication failed to adequately warn users or the medical community about the potential risk.
The complaint (PDF) was filed by Wade Tackett in the U.S. District Court for the Northern District of Illinois on February 14, indicating he began taking Uloric for treatment of gout in 2013.
Following several years of use, Tackett says he suffered a heart attack in 2015, which was allegedly caused by heart risks that were known to the drug maker, but not adequately described on the drug label until last year.
“Prior to Uloric’s original approval for marketing in the United States, Defendants interacted with FDA for nearly five years in an effort to obtain approval,” the lawsuit states. “In fact, due to concerns about the increased risk of cardiac thromboembolic events compared to placebo or allopurinol, Defendants were asked to provide further data to FDA before it would approve the NDA (new drug approval).”
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 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, including FDA concerns, when Uloric was first released, it appears the agency did not understand the true scope of the Uloric 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, yet continued to market the drug without adequate warnings.
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.