The FDA revised the label for canagliflozin on 2026-07-30, adding a boxed warning for metformin-associated lactic acidosis on the metformin hydrochloride label linked to this record. The warning states that postmarketing cases have led to death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
Canagliflozin is listed here alongside related products including Invokamet XR, Invokana, Invokamet, and canagliflozin and metformin hydrochloride. The source record is the FDA label entry for metformin hydrochloride, which is associated with this drug family in the provided data.
What this means
For clinicians and medication safety reviewers, the key change is the presence of a boxed warning highlighting a serious adverse reaction already known to occur in postmarketing use. The label language emphasizes that the onset of metformin-associated lactic acidosis is often subtle, so the warning may affect how prescribers monitor at-risk patients and counsel them about symptoms.
Source
This information is based on an FDA label revision dated 2026-07-30. The source document is available on dailymed.nlm.nih.gov at the provided record for setid 68d0b1a6-c99e-42cf-afdf-b71ee73c4424.