New Pioglitazone Label Highlights Bladder-Cancer Risk

August 05, 2011

August 5, 2011 (Silver Spring, Maryland) — The Food and Drug Administration has updated the label for pioglitazone (Actos, Takeda) to highlight the risk of cancer [1]. The updated label states that pioglitazone should not be started in patients with active bladder cancer and should be used with caution in patients with a prior history of bladder cancer.

In addition, the label states that patients should contact their physicians if they either experience blood or see a red color in their urine. Patients should also be aware of other symptoms that might be due to bladder cancer, including new or worsening urinary urgency or pain on urination since starting pioglitazone.

The agency announced June 15, 2011 that the label would be updated based on its safety review that confirmed earlier reports that use of pioglitazone for more than 12 months is associated with an increased risk of bladder cancer.

In early June, as reported by heartwire, the French Agency for the Safety of Health Products (AFSSAPS), suspended the marketing of pioglitazone (Actos, Takeda) after a study requested by AFSSAPS confirmed a small increase in bladder cancer among patients treated with the diabetes drug. German regulators recently announced that pioglitazone should not be started in new patients.

On July 21, 2011, the European Medicines Agency (EMA) issued an alert based on its own review, concluding that the benefit/risk balance of pioglitazone remains positive in a limited population of type 2 diabetics. The small increased risk of bladder cancer could be reduced by appropriate patient selection and exclusion, "including a requirement for periodic review of the efficacy and safety of the individual patient's treatment."

Like the FDA, the EMA concluded that pioglitazone should not be considered in patients with current or a history of bladder cancer or those with uninvestigated macroscopic hematuria.


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