European Medicines Evaluation Agency Warns About Takeda Pharmaceutical Co. Ltd.'s Actos, Backs Pfizer Inc.'s Champix, Restricts GlaxoSmithKline’s Pandemrix

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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