Canagliflozin: INVOKAMET label carries lactic acidosis warning

By Hipa.ai Research · August 24, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 27, 2026.

The U.S. Food and Drug Administration’s DailyMed record showed a boxed warning on the INVOKAMET label effective 24 August 2026. The warning concerned metformin-associated lactic acidosis and stated that post-marketing cases had resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

Background

INVOKAMET is identified in the supplied record as a canagliflozin product and is also listed under the name canagliflozin and metformin hydrochloride. The drug data also associate the label with canagliflozin, INVOKAMET XR, INVOKANA, and metformin hydrochloride. The label event specifically addressed the metformin-associated lactic acidosis warning.

What changed

The event was classified as an FDA label revision. The raw label headline stated that a boxed warning was present on the INVOKAMET label, with an effective date of 2026-08-24. The warning began with the heading “WARNING: LACTIC ACIDOSIS”.

Safety information in the warning

The supplied warning text said that post-marketing cases of metformin-associated lactic acidosis had resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. It also stated that the onset of metformin-associated lactic acidosis was often subtle. The provided record did not include additional prescribing instructions, risk factors, monitoring recommendations, incidence figures, or patient-level case details.

What this means

The label revision places the lactic acidosis warning prominently on the INVOKAMET labeling. Clinicians and other users reviewing the product information should consult the current label for the complete warning text and its associated prescribing information. The supplied data establish the presence and effective date of the boxed warning but do not provide a new clinical trial result, comparative safety analysis, or additional numerical estimate of risk.

Source

Source: U.S. Food and Drug Administration, DailyMed label record for INVOKAMET, with the label event effective 24 August 2026. The record is available through the DailyMed URL host at dailymed.nlm.nih.gov.