A boxed warning for lactic acidosis was added to the label of ZITUVIMET, a combination product containing canagliflozin and metformin hydrochloride, effective 2025-06-09. This warning highlights serious postmarketing cases of metformin-associated lactic acidosis, which have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
Canagliflozin is an SGLT2 inhibitor, approved for various indications related to type 2 diabetes, heart failure, and chronic kidney disease. ZITUVIMET is a fixed-dose combination product that includes canagliflozin and metformin hydrochloride. Metformin is a widely used oral antihyperglycemic agent for the management of type 2 diabetes. The risk of lactic acidosis is a known, serious adverse effect associated with metformin use.
What this means
The addition of a boxed warning for lactic acidosis to the ZITUVIMET label underscores the critical importance of monitoring for this severe adverse event in patients prescribed the medication. Clinicians should be aware of the symptoms and risk factors for metformin-associated lactic acidosis, which can be fatal. This label change reinforces the need for careful patient selection, monitoring of renal function, and patient education regarding the signs of lactic acidosis.
Source
The information regarding this label revision was obtained from the FDA via DailyMed. The update, effective 2025-06-09, is detailed in the prescribing information for ZITUVIMET on dailymed.nlm.nih.gov.