The European Medicines Agency has clarified its opinion on the scrutinized diabetes drug pioglitazone (Actos, Takeda Pharmaceuticals), a drug that received negative media reports earlier this year after it was found that it may increase the risk of cardiovascular events and incidence of bladder cancer.
In June, France and Germany pulled pioglitazone off the shelves after research showed that the drug increased the incidence of bladder cancer in diabetics administered the drug. While the FDA did not pull the drug from U.S. shelves, the agency did slap warnings on the drug’s label.
The EMA has clarified, at the request of the European Commission, that it stands behind pioglitazone as a valid treatment option for certain type 2 diabetic patients, but only when other treatments, such as metformin, have failed.
The EMA urged the public that the warnings and contraindications recommended in July remain in place.
In July, EMA recommended that pioglitazone remain on the market despite the small increased risk of bladder cancer. These recommendations were decided because a small number of patients cannot be adequately treated by other treatments, but the agency urged that prescribers carefully monitor patients on the drug.
“The latest amendments make it clearer for doctors and patients that pioglitazone remains a valid treatment option for certain patients with type 2 diabetes, but only when certain other treatments (metformin) have not been suitable or have failed to work adequately,” according to the EMA.
The agency will send the updated opinion to the European Commission for review.