Safety Information Added to Label of Diabetes Drug


Findings from an ongoing study show that long-term use of pioglitazone is associated with an increased risk of bladder cancer.

FDA recently issued a drug safety communication warning patients and health professionals that use of pioglitazone (Actos)—a prescription medication approved to improve glucose control in adults with type 2 diabetes—for more than 1 year may be linked to an increased risk of bladder cancer. This information will be added to the Warnings and Precautions section of the drug label and to the patient Medication Guide for all drugs containing pioglitazone.

The safety information is based on FDA’s review of data from a planned five-year interim analysis of an ongoing, 10-year study of more than 193,000 patients aged 40 years and older with diabetes in the Kaiser Permanent Northern California health plan. The 5-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.

FDA also cited an epidemiological study of approximately 1.5 million patients with diabetes conducted by the French National Health Insurance Plan from 2006 to 2009. In this study, there was a statistically significant increase in the risk of bladder cancer in patients who used pioglitazone compared with patients who used other antidiabetic agents after adjusting for age, sex, and use of other antidiabetic medications. The study also found that risk increased in patients with a cumulative dose of exceeding 28,000 mg or duration of treatment longer than 1 year. France has suspended the use of pioglitazone based on this study, while Germany has recommended that patients not start using the drug.

As a result of these findings, FDA recommended that health professionals avoid using pioglitazone in patients with active bladder cancer and use caution with prescribing the drug in patients with a prior history of bladder cancer. The agency will continue to evaluate data from the 10-year study, and will conduct a comprehensive review of the results.

In the meantime, the FDA issued the following information for patients:

  • There may be an increased chance of having bladder cancer when you take pioglitazone.
  • Do not take pioglitazone if you are receiving treatment for bladder cancer.
  • Report any of the following symptoms to a physician: blood or red color in urine; urgent need to urinate or pain while urinating; or pain in back or lower abdomen.
  • Read the Medication Guide that accompanies pioglitazone medicine to learn about the risks associated with its use.
  • Consult a health care professional if you have questions or concerns about pioglitazone medicines.
  • Report side effects from the use of pioglitazone medicines to the FDA MedWatch program by calling 1-800-332-1088 or visiting this site.

For more information or to read the data summary, click here.

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