The label for Metformin Hydrochloride now includes a new boxed warning regarding lactic acidosis, effective 2025-10-28. This warning highlights postmarketing cases of metformin-associated lactic acidosis, which have resulted in serious outcomes including death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of this condition is often subtle.
Background
Metformin Hydrochloride is a widely used medication, often prescribed for the management of type 2 diabetes. It is also available in combination formulations, such as with canagliflozin (e.g., Invokamet, Invokamet XR), an SGLT2 inhibitor. The addition of a boxed warning is a significant update to the drug's safety information.
What this means
The addition of a boxed warning for lactic acidosis on the Metformin Hydrochloride label underscores the critical importance for healthcare providers to monitor patients for signs and symptoms of this serious adverse event. Given the potential for subtle onset and severe consequences, including death, clinicians should be vigilant in assessing risk factors and educating patients about the symptoms of lactic acidosis. This label change reinforces the need for careful patient selection and ongoing monitoring during treatment with Metformin Hydrochloride.
Source
This information regarding the boxed warning for Metformin Hydrochloride was obtained from the U.S. Food and Drug Administration (FDA). The label revision, effective 2025-10-28, is documented on the DailyMed website, hosted by the National Library of Medicine (NLM) at dailymed.nlm.nih.gov.