Takeda Pharmaceutical Company Limited announced that at the request of the European Commission (EC), the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP) has clarified the label changes for pioglitazone-containing medicines recommended in July of this year. The updated opinion has been submitted to the European Commission and the EMA has indicated they expect it to be adopted by the Commission within the next two to three months. In July this year, following a review under Article 20 of Regulation (EC) No. 726/2004, the CHMP concluded that pioglitazone-containing medicines remain a valid treatment option for certain patients with type 2 diabetes. While a small increased risk of bladder cancer has been identified in patients taking these medicines, the CHMP concluded that this risk could be reduced by appropriate patient selection and exclusion, updated contraindications and warnings in the product labels, and periodic review of the efficacy and safety of the patient’s treatment.
