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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.

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Date created: August 14, 2007, updated August 22, 2007

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