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  • FDA Date: 08/04/2011

    Pioglitazone-Containing Medicines FDA Drug Safety Communication

    Updated Drug Labels for Pioglitazone-Containing Medicines

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than 1 year may be associated with an increased risk of bladder cancer. FDA previously communicated these labeling changes to the public on June 15, 2011.

    The updated drug labels recommend that healthcare professionals should:

    - Not use pioglitazone in patients with active bladder cancer.

    - Use pioglitazone with caution in patients with a prior history of bladder cancer.

    The updated drug labels recommend that patients should:

    Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.

    View the full FDA Drug Safety Communication on FDA.gov