Actos (Pioglitazone Hydrochloride) - FDA Alerts

FDA Alerts related to Actos (Pioglitazone)

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.