Canagliflozin Label Cites Revised Metformin Boxed Warning

By Hipa.ai Research · August 21, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 25, 2026.

On August 21, 2026, the FDA-listed labeling for metformin hydrochloride reflected a revised boxed warning on metformin-associated lactic acidosis. The warning states that postmarketing cases have resulted in death, along with hypothermia, hypotension, and resistant bradyarrhythmias.

Background

The affected labeling identifies metformin hydrochloride and is associated in the supplied drug record with canagliflozin products including Invokana, Invokamet, and Invokamet XR, as well as the combination described as canagliflozin and metformin hydrochloride. The event concerns the metformin hydrochloride label and its boxed warning, rather than a reported clinical trial or a new indication for canagliflozin.

What changed

The revised warning describes postmarketing reports of metformin-associated lactic acidosis. It states that these cases resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The supplied summary also states that the onset of metformin-associated lactic acidosis is often subtle, but the available text ends before providing additional warning details.

Label action: boxed warning revised.
Product label: Metformin Hydrochloride.
Effective date: August 21, 2026.
Safety issue named in the warning: metformin-associated lactic acidosis.

What this means

The revision makes the reported seriousness of metformin-associated lactic acidosis explicit in the boxed warning for the metformin hydrochloride labeling. Clinicians, researchers, patient advocates, and editors reviewing canagliflozin-associated combination products should verify the metformin component’s current labeling when assessing this safety language. The supplied data do not provide prescribing changes, patient-risk factors, monitoring instructions, incidence estimates, or evidence that the revision changes the approved indications for canagliflozin or metformin hydrochloride.

Source

Source: FDA, DailyMed drug-label document for Metformin Hydrochloride, effective August 21, 2026. The authoritative document is hosted at dailymed.nlm.nih.gov and is available at dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=073cf6d9-7142-4d8b-898e-174c62a1f76f.