Why did the FDA require Actos to update their label?

Actos contains pioglitazone, which may be harmful for patients with bladder cancer.  Therefore, on August 4, 2011 the FDA informed the public thorough a Safety Communication (https://www.fda.gov/Drugs/DrugSafety/ucm266555.htm), that it approved an update to the drugs warning label.  The purpose of the update was to inform the public that using Actos for more than one year may increase the risk of bladder cancer. 

The following are the updated changes to the label:

  • Doctors should not use pioglitazone in patients with active bladder cancer.
  • Doctors should use pioglitazone with caution in patients with a prior history of bladder cancer.
  • Patients should contact their healthcare professional if they experience any sign of blood 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.

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