Actos To Get Bladder Cancer Warnings In Europe And A Chance At A Rebound
This article was originally published in The Pink Sheet Daily
EU's top scientific advisory panel says Takeda's diabetes drug should have new contraindications and warnings about bladder cancer added to its prescribing information.
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The Endocrinologic and Metabolic Drugs Advisory Committee votes 9-6 against approval of the first-in-class SGLT-2 inhibitor, with panelists citing the need for more pre-approval data on the risk of bladder and breast cancer with the diabetes drug.
Europe's top regulatory advisory panel wants further analysis of Actos' link with bladder cancer, but recommends limiting indications for the NSAID nimesulide and adding contraindications for the cytoprotective dexrazoxane.
In an age of diabetes drug safety scares, will patients turn off of the thiazolidinedeione class altogether, or will the warning go unnoticed?