The label for Glyburide and Metformin Hydrochloride was updated on 2026-05-07 to include a new boxed warning. This significant label revision highlights the risk of lactic acidosis associated with metformin, a component of the drug, based on postmarketing cases.
Details of the Boxed Warning
The boxed warning, titled "WARNING: LACTIC ACIDOSIS," details serious adverse events. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The warning further states that "The onset of metforminassociated lactic acidosis is often subtle, accompa", indicating the challenging nature of early detection.
What this means
The addition of a boxed warning for lactic acidosis on the Glyburide and Metformin Hydrochloride label signifies a critical safety update for healthcare professionals. This warning emphasizes the severe, potentially fatal, nature of metformin-associated lactic acidosis. Clinicians are alerted to the subtle onset of this condition, which can complicate diagnosis and timely intervention. The reported outcomes, including death, hypothermia, hypotension, and resistant bradyarrhythmias, underscore the urgency of recognizing and managing this adverse event. This label change reinforces the need for careful patient monitoring and consideration of risk factors for lactic acidosis when prescribing or continuing treatment with metformin-containing products.
Source
This information is based on an FDA label revision for Glyburide and Metformin Hydrochloride, effective 2026-05-07. The details of the boxed warning are available on dailymed.nlm.nih.gov, identified by setid a58ff524-e975-4d51-a896-e869f8ea6624.