Takeda Pharmaceuticals has failed to warn users and the medical community about the cardiac risks with Uloric, according to allegations raised in a product liability lawsuit filed by a North Carolina woman who indicates that side effects of the gout medication caused her to develop unstable angina, chest pain, and multiple vessel coronary artery disease, which resulted in the need for heart surgery.
The complaint (PDF) was filed by Shelley Owens in the U.S. District Court for the Northern District of Illinois on November 22, indicating that Uloric creates a high risk of unreasonable harm, which was not adequately disclosed by the drug makers.
Owens states she began taking Uloric in 2012, for treatment of gout. About four years later, she began to experience various heart problems, which resulted in the need for medical treatment in November 2016, which she blames on Uloric side effects.
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 risks, leading the FDA to require new warnings earlier this 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.
“Defendants suppressed knowledge of, and failed to submit full and complete Periodic Adverse Drug Experience Reports to FDA, which evidenced any risks from Uloric associated with Drug/Drug Interaction while treating gout,” the lawsuit notes. “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 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.