• 04
  • November
    2011

At the moment, the FDA is warning doctors to weigh the risks of prescribing the diabetes drug Actos for patients who are being treated for bladder cancer or who have a history of bladder cancer, raising a red flag that Actos may be a dangerous drug.

Pioglitazone, marketed as Actos in the U.S. and one of the best-selling drugs in the nation, is used to help control blood sugar in patients with type 2 diabetes. It may even prevent patients with pre-diabetes from developing type 2 diabetes.

But shortly after health agencies in both France and Germany advised doctors not to prescribe pioglitazone, the FDA followed up shortly thereafter with its June 2011 safety report, part of an ongoing 10-year study of the drug.

The FDA's preliminary report indicates that patients who use Actos for more than one year and/or in higher doses may be at increased risk of bladder cancer. According to the FDA, signs of bladder cancer include:

  • Blood in the urine
  • Urgent need to urinate
  • Pain while urinating
  • Lower back pain
  • Lower abdomen pain

If you or someone you know has been experiencing adverse side effects after taking Actos, including any of the signs of bladder cancer, consult a doctor immediately. In addition to consulting with a doctor, you may report side effects of medication through the MedWatch program on the FDA's website.

Source: FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer