The label for Metformin Hydrochloride was revised on 2026-01-29 to include a boxed warning. This warning states: "WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accomp".
What this means
The addition of a boxed warning to the Metformin Hydrochloride label represents a significant safety update for healthcare professionals and patients. A boxed warning, also known as a black box warning, is the most stringent warning required by the FDA to highlight serious, potentially life-threatening adverse reactions. This specific warning underscores the severe risks associated with metformin-associated lactic acidosis, including fatal outcomes, hypothermia, hypotension, and resistant bradyarrhythmias. Clinicians should exercise heightened vigilance for the often subtle onset of this condition, ensuring careful patient selection, monitoring, and education regarding the symptoms of lactic acidosis when prescribing Metformin Hydrochloride.
Source
This label revision for Metformin Hydrochloride, effective 2026-01-29, was issued by the FDA. The details are available on dailymed.nlm.nih.gov.