An FDA label revision, effective 2026-05-21, has added a boxed warning concerning lactic acidosis to the label of glyburide and metformin hydrochloride. This update is particularly relevant for Canagliflozin prescribers and patients, as metformin hydrochloride is a component of certain Canagliflozin combination therapies, such as canagliflozin and metformin hydrochloride (Invokamet, Invokamet XR), and is the focus of the warning.
Key results
The revised label for glyburide and metformin hydrochloride now includes a boxed warning detailing the risk of lactic acidosis. This warning highlights that postmarketing cases of metformin-associated lactic acidosis have resulted in severe outcomes, including death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle.
What this means
The addition of a boxed warning for lactic acidosis to the label of glyburide and metformin hydrochloride underscores the critical importance of recognizing and managing this severe adverse event associated with metformin. For clinicians prescribing Canagliflozin in combination with metformin hydrochloride, this revision serves as a crucial reminder to consider the risk of lactic acidosis. Healthcare providers should counsel patients on the symptoms of lactic acidosis and monitor for risk factors, given the potential for subtle onset and severe consequences highlighted in the warning. Vigilance in identifying early signs of metformin-associated lactic acidosis is paramount to mitigate serious patient outcomes.
Source
The information regarding this label revision was obtained from the FDA. This document, an FDA label revision concerning glyburide and metformin hydrochloride, was effective on 2026-05-21 and is accessible via dailymed.nlm.nih.gov.