Canagliflozin/Metformin Label Revises Lactic Acidosis Warning

On September 9, 2026, the metformin hydrochloride label associated with canagliflozin/metformin products carried a revised boxed warning for lactic acidosis. The warning states that postmarketing cases of metformin-associated lactic acidosis resulted in death, as well as hypothermia, hypotension, and resistant bradyarrhythmias.

The supplied label summary also states that the onset of metformin-associated lactic acidosis is often—although the excerpt provided here does not complete that statement. The event was recorded as an FDA label revision affecting metformin hydrochloride.

Background

Canagliflozin is associated in the supplied product data with Invokana, Invokamet, Invokamet XR, and canagliflozin and metformin hydrochloride. The label event specifically names metformin hydrochloride and concerns metformin-associated lactic acidosis. The available data do not provide additional information about the products’ approved indications, dosing, mechanism, or the circumstances in which lactic acidosis occurred.

What this means

The revised boxed warning places serious postmarketing outcomes prominently on the metformin hydrochloride label. Clinicians, researchers, and patients reviewing canagliflozin/metformin product information should consult the current label for the complete warning language and its associated prescribing information. The supplied event data do not quantify the number of cases, identify risk factors, describe treatment recommendations, or compare safety outcomes among canagliflozin, metformin, dapagliflozin, or empagliflozin.

Because the available record is a label revision rather than a clinical trial report, it does not establish an incidence rate or provide a new comparative efficacy or safety analysis. The specific change documented here is the boxed warning language concerning metformin-associated lactic acidosis and its reported postmarketing consequences.

Source

Source: FDA, DailyMed label document for metformin hydrochloride, effective September 9, 2026. Available at dailymed.nlm.nih.gov, set ID d5228e81-9c86-4781-b984-20feaa2ae779.