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Actos – An Overview

The U.S. Food and Drug Administration (FDA) has announced that use of the diabetes medication Actos (pioglitazone) may be associated with an increased risk of bladder cancer. France and Germany have also taken action against the use of Actos due to similar findings about its dangerous side effects.


Actos, also known as pioglitazone, is an oral diabetes medicine that helps control blood sugar levels. It is for people with type 2 diabetes and can be used in combination with insulin or other medication. Actos cannot be used in type 1 diabetes treatment.


The new safety information comes from a FDA review of data from an ongoing epidemiological study. So far, the results showed there was no overall increased risk of bladder cancer with pioglitazone use; however, an increased risk of bladder cancer was noted among:

  • Patients with the longest exposure to pioglitazone
  • Patients exposed to the highest cumulative dose of pioglitazone
  • Sold as a single-ingredient product under the brand-name Actos. Also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact)
  • Used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus
  • From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies

According to the safety announcement, information about this risk will be added to the “Warnings and Precautions” section of the label for pioglitazone-containing medicines. Additionally, the FDA recommends healthcare professionals:

  • Should not use pioglitazone in patients with active bladder cancer
  • Should use pioglitazone with caution in patients with a prior history of bladder cancer (the benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence)


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