On August 25, 2026, an FDA-listed label revision revised the boxed warning for a label identified in the source headline as alogliptin and metformin hydrochloride. The warning concerns metformin-associated lactic acidosis, with postmarketing cases reported to have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
The supplied drug record identifies canagliflozin as the primary drug and lists metformin hydrochloride among its related names. The event headline, however, identifies the revised labeling as applying to alogliptin and metformin hydrochloride. The provided data do not describe canagliflozin’s mechanism, dosing, approved indications, or the specific relationship between canagliflozin and the label named in the event headline.
What changed
The boxed warning was revised effective August 25, 2026. Its warning text states that postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The supplied summary also states that onset is often subtle, but the excerpt does not provide the remainder of the warning text.
What this means
The revision highlights the seriousness of metformin-associated lactic acidosis and adds or clarifies severe outcomes reported after marketing. The available data do not provide case counts, incidence estimates, patient characteristics, risk factors, management recommendations, or comparative safety findings. They also do not establish a new indication or approval for canagliflozin.
Source
Source: FDA, DailyMed label document, effective August 25, 2026. The source is available through dailymed.nlm.nih.gov at dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=14d98490-4f8f-4d2f-a4e9-7a3d7a0199ba.