Effective August 12, 2026, the FDA DailyMed label identified in this record carried a boxed warning for metformin hydrochloride. The warning addressed metformin-associated lactic acidosis and stated that postmarketing cases had resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
The event record is associated with canagliflozin and lists Invokana, Invokamet, Invokamet XR, canagliflozin and metformin hydrochloride, and metformin hydrochloride among the drug names. The source headline specifically described a boxed warning on the metformin hydrochloride label. The available data do not provide additional information about canagliflozin’s indication, dosing, mechanism, or the relationship between the listed products.
Label change
The event was classified as an FDA label revision effective on 2026-08-12. The label carried the warning heading “WARNING: LACTIC ACIDOSIS”. The supplied warning text said that postmarketing cases of metformin-associated lactic acidosis had resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
What this means
For clinicians and other users reviewing the affected label, the key safety information is the presence of a boxed warning for metformin-associated lactic acidosis. The record also stated that onset was often subtle, although the supplied summary ended before providing the remainder of that warning. This data block does not provide incidence estimates, risk factors, monitoring instructions, treatment recommendations, or information about any change to canagliflozin’s labeling.
The record does not describe a clinical trial, new indication, efficacy finding, comparator, or adverse-event analysis. It also does not establish whether the revision changed the wording of an existing warning or added a new warning beyond the fact that a boxed warning was present on the identified metformin hydrochloride label.
Source
This article is based on an FDA label-revision record effective August 12, 2026. The source document is the DailyMed metformin hydrochloride label, available through dailymed.nlm.nih.gov at the supplied URL.