On August 4, 2011, the US Food and Drug Administration (FDA) issued a warning that use of Actos (known generically as pioglitazone) for more than one year could be associated with an increased risk of bladder cancer. That information came from an interim review of a long-term study. A different study, conducted in France, also suggested a link between the use of Actos and the development of bladder cancer. Based on that information, France suspended the use of Actos while Germany recommended that new patients not be started on the medication.
Recently, concerns about the safety of Actos were raised by a whistleblower, Helen Ge, who alleged in a lawsuit that Takeda Pharmaceuticals, maker of Actos, failed to properly report adverse events associated with Actos to the FDA, as required.
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In a different lawsuit, a judge has appointed 19 plaintiffs' lawyers to manage ongoing Actos litigation.
Actos became a top-selling type II diabetes medication after Avandia sales were severely restricted by the FDA. That move came after Avandia was linked to an increased risk of heart attacks. The first hearings in the large-scale lawsuit were set to begin on March 22.