A boxed warning for lactic acidosis was added to the label of JANUMET (sitagliptin and metformin HCl), effective July 13, 2026. This significant label revision highlights the risk of metformin-associated lactic acidosis, a serious and potentially fatal adverse event.
Background
JANUMET is a combination medication that includes metformin hydrochloride, an agent known to carry a risk of lactic acidosis. This condition is a rare but serious metabolic complication associated with metformin use, characterized by the accumulation of lactic acid in the bloodstream.
What this means
The addition of a boxed warning for lactic acidosis to the JANUMET label underscores the critical importance for healthcare professionals to monitor patients for symptoms. The warning explicitly states that postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. It also highlights that the onset of metformin-associated lactic acidosis is often subtle. This update necessitates careful patient selection, ongoing monitoring, and thorough patient education regarding the signs and symptoms of this serious and potentially fatal adverse event. Early recognition and management are crucial given the severe outcomes associated with this condition.
Source
This information was sourced from the FDA, detailing a label revision for JANUMET (sitagliptin and metformin HCl) effective July 13, 2026. The updated label information is available on dailymed.nlm.nih.gov.