An FDA-linked DailyMed label for Glyburide and Metformin Hydrochloride was effective on 18 August 2026 and listed a boxed warning for metformin-associated lactic acidosis. The warning states that postmarketing cases resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
The supplied record identifies canagliflozin and related product names including Invokana, Invokamet, and Invokamet XR. It also identifies glyburide and metformin hydrochloride in the label headline. The warning described in the record concerns metformin-associated lactic acidosis.
What changed
The event was classified as an FDA label revision. The label headline states that a boxed warning was present on the Glyburide and Metformin Hydrochloride label, with an effective date of 18 August 2026.
The warning text begins: “WARNING: LACTIC ACIDOSIS.” It reports that postmarketing cases of metformin-associated lactic acidosis resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The supplied warning summary also states that onset is often subtle, but the available record does not provide the remainder of that statement.
What this means
The record documents the presence of a boxed warning on the specified glyburide and metformin hydrochloride label. It highlights the seriousness of reported metformin-associated lactic acidosis and identifies several outcomes reported in postmarketing cases. The supplied data do not establish that this label revision changed the canagliflozin label, provide prescribing instructions, or describe the frequency of the reported events.
Source
Source: FDA, DailyMed drug-label document for Glyburide and Metformin Hydrochloride, effective 18 August 2026. The source is available through dailymed.nlm.nih.gov at dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4dcef36f-000e-43f5-8d67-0e2a079ab2c6.