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European Medicines Evaluation Agency Warns About Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Actos, Backs Pfizer Inc. (PFE)'s Champix, Restricts GlaxoSmithKline (GSK)'s Pandemrix


7/22/2011 8:23:25 AM

Europe's regulator has given its support to continued use of Takeda's diabetes pill Actos but has recommended new contraindications and warnings be added to the label regarding a "small increased risk of bladder cancer". Last month, France and Germany suspended use of Actos (pioglitazone) and Competact (pioglitazone/metformin) following new data from a retrospective study which appears to indicate a slight increased risk of bladder cancer with pioglitazone-containing medicines. However, having completed its review which began in March, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) says medicines containing pioglitazone "remain a valid treatment option for certain patients with type 2 diabetes".


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