Actos (pioglitazone), manufactured by Takeda Pharmaceuticals, is a popular medication used to treat type 2 diabetes. Recently, numerous lawsuits warning about the risk of bladder cancer associated with Actos have arisen. Regardless, the FDA authorized a generic version of the drug on August 17, 2012, manufactured by Mylan Pharmaceuticals. Both the brand and generic forms will carry the same warnings, including a Boxed Warning to emphasize that pioglitazone may cause or worsen heart failure, and a warning that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.
Commentators have expressed dissatisfaction with the FDA’s approval of the generic drug despite a wave of studies, recalls and warnings associated with pioglitazone.
Despite the FDA’s approval of the generic pioglitazone drug, the Actos lawsuits continue to thrive. On July 13, 2012, the Honorable Rebecca Doherty, who is overseeing the federal consolidated action currently underway in the U.S. District Court for the Western District of Louisiana, issued an order sending the first federal Actos bladder cancer lawsuit trial on November 3, 2014 with the second trial set for July 8, 2015. Plaintiffs involved in the Actos litigation allege that the drug caused them to develop bladder cancer and that the manufacturer failed to warn consumers about the risks associated with Actos use.
