On August 26, 2026, the FDA recorded a revision to the boxed warning on the metformin hydrochloride label associated with the canagliflozin product record. The warning addresses metformin-associated lactic acidosis and states that postmarketing cases have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
Canagliflozin is listed in the supplied drug record alongside the product names Invokana, Invokamet, and Invokamet XR. The record also identifies canagliflozin and metformin hydrochloride as related product names. The label change specifically concerns metformin hydrochloride, rather than reporting a new indication or clinical trial result for canagliflozin.
The revised warning concerns metformin-associated lactic acidosis. The supplied FDA label text describes the condition as potentially fatal and reports postmarketing cases involving death, hypothermia, hypotension, and resistant bradyarrhythmias. It also states that onset is often subtle; the supplied warning excerpt ends before the remainder of that sentence.
What changed
The event was classified as an FDA label revision with an effective date of August 26, 2026. The concrete change identified in the data was a revision to the boxed warning for metformin hydrochloride. The supplied information does not describe the wording that preceded the revision, identify additional labeling sections that changed, or provide prescribing instructions beyond the warning excerpt.
The data do not report a new approval, a new patient population, dosing changes, comparative efficacy results, or clinical-trial measurements. They also do not provide a frequency estimate for lactic acidosis, a risk comparison among products, or further details about the reported postmarketing cases. Accordingly, the event supports reporting the boxed-warning revision and the serious outcomes named in the label, but not conclusions about the relative safety of canagliflozin, metformin, or related products.
What this means
For clinicians, researchers, and patient advocates reviewing the record, the key label-safety point is that the metformin hydrochloride boxed warning was revised effective August 26, 2026. The warning highlights the seriousness of metformin-associated lactic acidosis and identifies death, hypothermia, hypotension, and resistant bradyarrhythmias among reported outcomes. The supplied data do not establish whether the revision changes treatment selection or monitoring requirements.
Source
Source: FDA, DailyMed label document for metformin hydrochloride associated with the canagliflozin product record, effective August 26, 2026. The document is available through dailymed.nlm.nih.gov at dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fb296500-55cb-45ce-be0c-59aa2e3d4624.