The FDA revised the boxed warning on the ZITUVIMET label effective August 12, 2026. The warning cites postmarketing cases of metformin-associated lactic acidosis, including reports involving death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
The event data identifies canagliflozin as the drug associated with this label revision. The listed product and related names include ZITUVIMET, INVOKANA, INVOKAMET XR, INVOKAMET, canagliflozin and metformin hydrochloride, and metformin hydrochloride. The available data describe a labeling action rather than a clinical trial or new efficacy finding.
What changed
The ZITUVIMET label received a revised boxed warning. The warning is headed “Lactic Acidosis” and directs readers to the full prescribing information for the complete boxed warning. The supplied FDA summary specifically identifies postmarketing cases of metformin-associated lactic acidosis.
According to the warning summary, reported outcomes included death, hypothermia, hypotension, and resistant bradyarrhythmias. The available event record does not provide case counts, incidence estimates, risk percentages, patient characteristics, or comparative safety analyses.
What this means
The revision places metformin-associated lactic acidosis in the boxed-warning language for the ZITUVIMET label. Clinicians, researchers, and patients reviewing the product information should consult the complete prescribing information for the warning’s full text and context. This record does not describe a change in dosing, a new indication, a contraindication, or evidence from a randomized trial.
Source
This article is based on a FDA label revision effective 2026-08-12. The source document is the DailyMed product-label record identified by set ID 0098dec4-f0e5-45d5-8aa4-5d0faf9ab142, available at dailymed.nlm.nih.gov.