FDA adds bladder cancer warning to pioglitazone label

The FDA has approved label changes to the diabetes drug pioglitazone (Actos, Takeda) and medications that contain it after interim findings from an epidemiological study indicate that using the drug for longer than one year increases patients' risk for bladder cancer.

The updated label advises clinicians to avoid using the drug in patients with active bladder cancer and recommends caution in patients with a prior history of bladder cancer.

The warning will also appear on pioglitazone/metformin (Actoplus Met), pioglitazone/metformin extended release (Actoplus Met XR) and pioglitazone/glimepiride (Duetact).

The FDA encourages patients who are taking these drugs to contact their health care provider if they notice any sign of blood in the urine, any new or worsening urinary urgency or pain during urination.

The agency first issued a warning about the risk for bladder cancer with pioglitazone in June, after an analysis of data from 193,099 patients with diabetes revealed that those taking the drug for more than a year had a 40% increased risk for bladder cancer. However, the findings were of limited statistical significance, according to the FDA.

At that time, France and Germany banned pioglitazone based on the data, which indicated a 1.4-fold increased risk of bladder cancer after two years of treatment.

The drug's manufacturer, Takeda, announced that it planned to continue the 10-year study through it's projected finish date at the end of 2012.

Pioglitazone is the second diabetes medication in the thiazolidinedione class associated with serious side effects.  Last fall, the FDA severely restricted rosiglitazone (Avandia, GlaxoSmithKline) due to concerns about risk for myocardial infarction.

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