Canagliflozin Label Lists Boxed Warning for Metformin

On 27 August 2026, an FDA-listed label revision identified a boxed warning on the metformin hydrochloride label associated with canagliflozin-related products. The warning concerns metformin-associated lactic acidosis and states that postmarketing cases have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

Background

Canagliflozin is associated in the supplied drug data with the product names Invokana, Invokamet, Invokamet XR, and canagliflozin and metformin hydrochloride. The label revision specifically describes a boxed warning on the metformin hydrochloride label. The supplied information does not provide additional details about canagliflozin’s mechanism, dosing, approved indications, or how the warning applies to individual products.

Label change

The event was classified as an FDA label revision. Its headline states that a boxed warning was present on the metformin hydrochloride label, effective 27 August 2026. The warning is titled “WARNING: LACTIC ACIDOSIS.” It reports that postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

The supplied warning summary also states that the onset of metformin-associated lactic acidosis is often subtle, but the available data end before providing the remainder of that statement. No contraindications, monitoring instructions, risk factors, incidence figures, or changes to canagliflozin’s indication were supplied.

What this means

The revision places a serious safety warning on the metformin hydrochloride labeling connected with the listed canagliflozin combination products. Clinicians and other label users should consult the complete current labeling when evaluating metformin-containing therapy and suspected lactic acidosis.

This event does not, on the supplied facts alone, establish a new indication, a dosing change, or a canagliflozin-specific safety rate. It also does not provide comparative evidence involving dapagliflozin or empagliflozin, which were listed as related drugs.

Source

Source: U.S. Food and Drug Administration, DailyMed label record for metformin hydrochloride, with the label revision effective 27 August 2026. The source is available through dailymed.nlm.nih.gov at the provided DailyMed lookup URL.