New Guidance on Actos or Takeda

FDA announced an increased risk of bladder cancer has been found in patients taking Actos or Takeda

(RxWiki News) If you've been taking Actos or Takeda for more than a year to control your type 2 diabetes, you will want to be in touch with your family physician or endocrinologist. A link with bladder cancer has been discovered.

The U.S. Food and Drug Administration (FDA) announced that in its ongoing 10-year study, an increased risk of bladder cancer has been found in patients taking Actos or Takeda for more than one year. Both medicines contain pioglitazone.

"Talk to your doctor if you're taking Actos or Takeda."

Leaders in the field of diabetes from the FDA, The Endocrine Society, the American Association of Clinical Endocrinologists and the American Diabetes Association caution patients taking these medicines to continue taking them unless their healthcare provider instructs otherwise.

Medical societies urge patients to follow the FDA guidance:

  • Pioglitazone-containing medications (Actos and Takeda) may increase chance of developing bladder cancer when taking pioglitazone;
  • Pioglitazone should not be taken if you're being treated for bladder cancer;
  • Call your doctor immediately if you have any of these symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen
  • Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines

The FDA warnings came after the review of a five-year interim analysis of an ongoing ten-year study. Although there was no overall increased risk of bladder cancer with pioglitazone use, there is anincreased risk of bladder cancer among patients who had been on pioglitazone the longest and had been on higher doses over time.

Being treated with pioglitazone for more than 12 months was associated with a 40% increase in the risk for bladder cancer vs. never being taken pioglitazone.

This risk will be added to the warnings and precautions section on the labels of pioglitazone-containing medicines and in the patient medication guide for these medicines.

Review Date: 
June 20, 2011