On 2026-08-03, the FDA label for canagliflozin products that include metformin hydrochloride carried a boxed warning for lactic acidosis. The warning highlights postmarketing cases of metformin-associated lactic acidosis, including deaths, and notes that onset is often subtle.
Background
Canagliflozin is marketed in products such as Invokana, Invokamet, and Invokamet XR. This label revision applies to the metformin hydrochloride component of the combination products listed in the record.
What this means
A boxed warning is the strongest safety warning on a prescription label and is meant to draw attention to serious, potentially fatal risk. Based on the FDA label, clinicians reviewing canagliflozin-containing products with metformin should pay close attention to the lactic acidosis warning and the possibility that symptoms may not be dramatic at presentation.
Source
This information is based on an FDA label record dated 2026-08-03. The document is available on dailymed.nlm.nih.gov at the cited setid=59a4ccda-5487-4ac4-9373-0c0fc8b7c88b page.