Canagliflozin Label Carries Metformin Lactic Acidosis Warning

On August 28, 2026, an FDA DailyMed label for metformin hydrochloride associated with canagliflozin products included a boxed warning for lactic acidosis. The warning states that postmarketing cases of metformin-associated lactic acidosis have resulted in death, along with hypothermia, hypotension, and resistant bradyarrhythmias.

Background

Canagliflozin is listed in the supplied record with the brand names Invokana, Invokamet, and Invokamet XR. The record also identifies canagliflozin and metformin hydrochloride as related product names. The label event concerns metformin hydrochloride and its warning language, rather than a reported clinical trial or efficacy finding for canagliflozin.

Label change

The FDA DailyMed label carried the heading “WARNING: LACTIC ACIDOSIS.” It described postmarketing cases of metformin-associated lactic acidosis and reported that these cases 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. The available record ends before providing additional warning text, risk factors, monitoring instructions, or management recommendations.

What this means

The event documents the presence of a boxed warning on the metformin hydrochloride label effective August 28, 2026. For clinicians, researchers, and patient advocates reviewing canagliflozin products that include metformin hydrochloride, the record identifies lactic acidosis as the safety issue emphasized by the label.

The supplied data do not include new dosing information, comparative safety analyses, incidence estimates, clinical-trial results, or a change to an indication. They also do not establish that the warning applies to canagliflozin products without metformin hydrochloride.

Source

Source: FDA, DailyMed labeling document for metformin hydrochloride, effective August 28, 2026. The source is available through dailymed.nlm.nih.gov at https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c568d49f-c040-4f1e-ad36-77b05ab659c3.