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U.S. Department of Health and Human Services


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FDA Drug Safety Podcast for Healthcare Professionals: Updated drug labels for pioglitazone-containing medicines

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Welcome, my name is Steve Jackson , a pharmacist in the Division of Drug Information. On August 4, 2011, the Food and Drug Administration issued a Drug Safety Communication 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 one year may be associated with an increased risk of bladder cancer. FDA previously communicated these labeling changes to the public in a June 15, 2011 Drug Safety Communication.

The updated drug labels recommend that healthcare professionals should:

  1. Not use pioglitazone in patients with active bladder cancer.
  2. 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.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Healthcare professionals can access the latest drug labels for pioglitazone-containing medicines in the complete Drug Safety Communication that can be found at www.fda.gov/Drugs/DrugSafety. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.





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