Canagliflozin record flags boxed warning for lactic acidosis

By Hipa.ai Research · August 12, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 18, 2026.

An FDA-linked DailyMed record identified a boxed warning for lactic acidosis effective August 12, 2026. The warning concerns postmarketing cases of metformin-associated lactic acidosis, which the record says resulted in death, hypothermia, hypotension, and resistant brad... The event data are associated with Canagliflozin, but the headline identifies the affected label as sitagliptin and metformin hydrochloride.

Background

The data identify Canagliflozin and related product names including Invokana, Invokamet, Invokamet XR, canagliflozin and metformin hydrochloride, and metformin hydrochloride. The event itself concerns a label for sitagliptin and metformin hydrochloride. The supplied record does not provide mechanism, dosing, indication, or prevalence information.

What changed

The event was classified as an FDA label revision. Its headline states that a boxed warning was present on the sitagliptin and metformin hydrochloride label, effective 2026-08-12. The warning text begins: “WARNING: LACTIC ACIDOSIS.” It directs readers to the full prescribing information for the complete boxed warning.

Safety information in the warning

The supplied warning summary says that postmarketing cases of metformin-associated lactic acidosis resulted in death, hypothermia, hypotension, and resistant brad... The provided data truncate the final description after “resistant brad,” so the remainder of that phrase cannot be reported from this record.

What this means

The record signals that lactic acidosis is addressed in boxed-warning language on the identified sitagliptin and metformin hydrochloride label. Because the supplied data do not describe prescribing recommendations, risk factors, incidence, patient-management instructions, or a change specific to Canagliflozin, they do not support additional clinical interpretation.

Source

This article is based on an FDA-linked DailyMed label record, effective August 12, 2026. The source is the DailyMed document available through dailymed.nlm.nih.gov, set ID e07abcb1-1f0c-4cad-8405-8eedba4b8ff8.