The FDA revised the boxed warning on the metformin hydrochloride label, effective 2026-08-04. The warning highlights postmarketing cases of metformin-associated lactic acidosis, including reports that resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
Metformin hydrochloride is listed on the label for products that include metformin hydrochloride and combination products such as canagliflozin and metformin hydrochloride. The label revision applies to the FDA-labeled product information for this drug.
What this means
The revised boxed warning reinforces the risk of metformin-associated lactic acidosis and the need for clinicians to recognize that the onset is often subtle. For readers tracking canagliflozin-related combination products, the label change is relevant because the metformin component appears in fixed-dose combinations such as Invokamet and Invokamet XR.
Source
This information is based on an FDA label revision dated 2026-08-04, available through DailyMed at dailymed.nlm.nih.gov under setid 4d087f00-580b-4b9d-80d9-f97930153e72.