On September 2, 2026, an FDA DailyMed label record associated with canagliflozin showed a boxed warning on the Glumetza label. The warning concerned metformin-associated lactic acidosis and stated that postmarketing cases had resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
The label record referenced Glumetza and identified metformin-associated lactic acidosis as the subject of the boxed warning. The supplied record also listed canagliflozin, Invokana, Invokamet, Invokamet XR, canagliflozin and metformin hydrochloride, and metformin hydrochloride among the associated drug names.
What changed
The label record indicated that a boxed warning was present and effective on September 2, 2026. Its warning text described postmarketing cases of metformin-associated lactic acidosis that resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. It also stated that the onset of metformin-associated lactic acidosis was often subtle.
What this means
The record highlights a serious safety warning concerning metformin-associated lactic acidosis on the Glumetza label. The supplied data do not provide case counts, incidence estimates, patient characteristics, dosing information, or additional prescribing recommendations.
Source
Source: FDA, DailyMed label record for Glumetza, effective September 2, 2026. Available at dailymed.nlm.nih.gov.