Drugs
Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact) Information
FDA ALERT [8/2007] This Alert highlights important revisions to the full prescribing information for pioglitazone HCl, marketed as Actos, Actoplus Met, and Duetact. The updated information includes a new BOXED WARNING, and additional updated WARNINGS, PRECAUTIONS and CONTRAINDICATIONS to emphasize that pioglitazone may cause or exacerbate heart failure, particularly in certain patient populations. The implications of this new labeling for healthcare professionals who prescribe Actos are summarized below. This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
Related Information
FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines
8/4/2011FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
6/15/2011FDA Drug Safety Podcast for Healthcare Professionals: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure
9/17/2010FDA reviewing preliminary safety information on Actos (pioglitazone)
FDA Note to Correspondence - 9/17/2010Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer
MedWatch - 9/17/2010Information for Healthcare Professionals: Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact)
FDA ALERT [8/2007]Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
FDA news release (8/14/2007)
Labeling and Regulatory History from Drugs@FDA
Regulatory History of Pioglitazone from Drugs@FDA Regulatory History of Pioglitazone Actos - Prescribing Information
Actos labeling with boxed warning approved (8/14/2007)
Contact FDA
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