EMA advices Takeda to change diabetes drug label

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that pioglitazone-containing medicines remain a valid treatment option for patients with type 2 diabetes.

The CHMP thought to include new contraindications and warnings in the product labels to reduce the risk of bladder cancer and to select and exclude patient and periodic review of the efficacy and safety of the patient’s treatment.

The CHMP took up the European review of pioglitazone-containing medicines in March this year to investigate the signal of a possible increased risk of bladder cancer with use of pioglitazone.

Under the review process CHMP evaluated all available data on the occurrence of bladder cancer, including results of preclinical studies, clinical studies, epidemiological studies and spontaneous reports, to evaluate the balance of benefits and risks of pioglitazone-containing medicines.

The Committee also considered the advice from its Scientific Advisory Group (SAG) on Diabetes/Endocrinology.

Takeda said it will work with the EMA to implement the decision across Member States, and will update physician and patient information to reflect these changes.