On September 8, 2026, an FDA-listed labeling record showed a boxed warning present on the metformin hydrochloride label associated with canagliflozin products. The warning states that postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
The event record identifies canagliflozin as the drug and lists Invokana, Invokamet, Invokamet XR, canagliflozin and metformin hydrochloride, and metformin hydrochloride among the associated names. The labeling event specifically concerns the metformin hydrochloride label, rather than providing a new indication or clinical-trial finding for canagliflozin.
What changed
The label carried a boxed warning headed “WARNING: LACTIC ACIDOSIS.” The warning describes postmarketing reports of metformin-associated lactic acidosis and identifies several reported outcomes: death, hypothermia, hypotension, and resistant bradyarrhythmias. The supplied warning text also states that onset is often subtle and ends mid-sentence in the source data.
What this means
The revision places the lactic-acidosis risk prominently in the metformin hydrochloride labeling. For readers reviewing canagliflozin products that include metformin hydrochloride, the record indicates that this boxed warning was effective on September 8, 2026. The supplied data do not provide dosing instructions, risk factors, incidence estimates, comparative safety results, or additional management recommendations.
Source
Source: FDA, DailyMed label record for metformin hydrochloride, with the labeling event effective September 8, 2026. Available at dailymed.nlm.nih.gov, record set ID 7cc02a26-5c22-445b-ad8f-3e7570c143d3.