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.
Healthcare Professional Information
- Information for Healthcare Professionals: Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact)
FDA ALERT [8/2007] - Actos - Prescribing Information
Actos labeling with boxed warning approved 8/14/2007)
Other Information
- Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
8/14/2007 - Regulatory History of Pioglitazone from Drugs@FDA
Regulatory History of Pioglitazone
Contact Us
- 1-800-332-1088
- 1-800-FDA-0178 Fax
Report a Serious Problem
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787