FDA updates diabetes drug label, citing increased bladder cancer risk

August 18, 2011

The FDA has approved updated drug labels for medications containing pioglitazone (Actos), an agent used to treat type 2 diabetes. The new labels are part of an update to the agency?s ongoing safety review of pioglitazone and increased risk of bladder cancer.

The FDA has approved updated drug labels for medications containing pioglitazone (Actos), an agent used to treat type 2 diabetes. The new labels are part of an update to the agency’s ongoing safety review of pioglitazone and increased risk of bladder cancer.

The new labels recommend that pioglitazone not be given to patients with active bladder cancer and should be used with caution in those with a prior history of bladder cancer, as use of the drug for more than 1 year may be associated with increased risk of bladder tumors.

The labels further suggest that patients should consult their health care professional if they experience any sign of hematuria, new or worsening urinary urgency, or pain when urinating since starting pioglitazone.