Pioglitazone is sold as a single-ingredient product under the brand-name Actos and is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). It is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
FDA Drug Safety Communication: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer
FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines[ARCHIVED]
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer[ARCHIVED]
FDA Drug Safety Podcast for Healthcare Professionals: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure[ARCHIVED] FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure[ARCHIVED]
FDA reviewing preliminary safety information on Actos (pioglitazone)[ARCHIVED]
FDA Note to Correspondence - 9/17/2010
Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer
MedWatch - 9/17/2010
Information for Healthcare Professionals: Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact)[ARCHIVED]
FDA ALERT [8/2007]
Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk[ARCHIVED]
FDA news release (8/14/2007)