An FDA label-revision record dated August 13, 2026, identified a boxed warning for lactic acidosis on a label for sitagliptin and metformin hydrochloride. The record’s warning states that postmarketing cases of metformin-associated lactic acidosis resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
The data record is associated with canagliflozin and lists related product names including Invokana, Invokamet, Invokamet XR, canagliflozin and metformin hydrochloride, and metformin hydrochloride. However, the event headline specifically identifies the sitagliptin and metformin hydrochloride label. The supplied data do not describe a new canagliflozin indication, dosing change, mechanism, or clinical-trial result.
What changed
The event was classified as an FDA label revision and described the boxed warning as present on the label, effective August 13, 2026. The warning heading was “LACTIC ACIDOSIS.” Its text reported that postmarketing cases of metformin-associated lactic acidosis had resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
The supplied warning summary also stated that the onset of metformin-associated lactic acidosis is often subtle, but the available text ends after “accomp.” The data do not provide the remainder of that sentence or additional prescribing instructions.
What this means
The record documents a boxed warning concerning metformin-associated lactic acidosis on the identified sitagliptin-metformin label. It does not establish that canagliflozin itself received a new boxed warning, nor does it provide comparative safety data, event rates, or patient-level outcomes. Clinicians and editors should distinguish the canagliflozin association in the data record from the specific label named in the event headline.
Source
This article is based on an FDA-linked DailyMed label record, with an effective date of August 13, 2026. The source document is available through dailymed.nlm.nih.gov at the provided DailyMed lookup URL.