On 21 August 2026, an FDA-listed DailyMed label for Actoplus Met carried a boxed warning for congestive heart failure and lactic acidosis. The warning states that thiazolidinediones, including pioglitazone, a component of Actoplus Met, can cause or exacerbate congestive heart failure in some patients.
The supplied record identifies the drug event under canagliflozin, while the label headline and warning text concern Actoplus Met. The event was classified as an FDA label revision and marked as major.
Background
Actoplus Met is the product named in the label record. The warning identifies pioglitazone as one of its components and describes pioglitazone as a thiazolidinedione. The supplied label summary also names lactic acidosis as a boxed-warning topic. No additional indication, dosing information, mechanism details, or prevalence figures were provided in the record.
What this means
The label information places two serious safety concerns at the front of the Actoplus Met labeling: congestive heart failure and lactic acidosis. In particular, the warning says that thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients. The supplied data do not provide patient-selection criteria, incidence figures, comparative safety results, or further instructions for clinical management.
Source
Source: FDA, DailyMed drug-label record for Actoplus Met, effective 21 August 2026. The authoritative record is available at dailymed.nlm.nih.gov.