An FDA label revision effective September 2, 2026, recorded a boxed warning on the metformin hydrochloride label associated with a canagliflozin-related drug record. The warning concerns metformin-associated lactic acidosis and states that postmarketing cases have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
The supplied record identifies canagliflozin as the drug and lists Invokana, Invokamet, Invokamet XR, canagliflozin and metformin hydrochloride, and metformin hydrochloride among its drug names or aliases. The event headline specifically describes a boxed warning present on the metformin hydrochloride label. The record does not provide additional information about the drug’s mechanism, approved indications, dosing, or patient population.
What this means
The label warning identifies metformin-associated lactic acidosis as a serious postmarketing safety concern. The FDA summary states that reported cases have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. It also states that the onset of metformin-associated lactic acidosis is often subtle, although the supplied record ends before providing further warning text.
This event should therefore be interpreted as a labeling record concerning metformin hydrochloride and lactic acidosis. The supplied data do not describe a new clinical trial, comparative effectiveness finding, incidence estimate, risk subgroup, treatment recommendation, or change to canagliflozin’s clinical outcomes.
Source
Source: U.S. Food and Drug Administration, DailyMed label record for metformin hydrochloride, with the revision effective September 2, 2026. Available at dailymed.nlm.nih.gov.