Europe Holds Firm on Actos, Allowing It to Stay

A committee for the European Medicines Agency has reaffirmed an earlier decision to allow the type 2 diabetes drug pioglitazone (Actos) to remain on the market despite a risk of bladder cancer. In July, the Committee for Medicinal Products for Human Use (CHMP) recommended that new labeling warning of the associated cancer risk be placed on the drug, but did not advise taking the drug off the market. A month earlier, however, France and Germany had advised doctors to stop prescribing the drug. In upholding its July decision, the CHMP said that, “Pioglitazone remains a valid treatment option for certain patients with type 2 diabetes, when certain other treatments (metformin) have not been suitable or have failed to work adequately.” Final decision is expected in the next 2-3 months. In August, the FDA approved an updated label warning on the increased risk of bladder cancer when pioglitazone is used for more than a year. Committee for the European Medicines Agency, Oct. 2011