The label for Synjardy, a combination medication containing empagliflozin and metformin hydrochloride, received a new boxed warning for lactic acidosis, effective January 30, 2026. This significant label revision by the FDA highlights the serious risk of metformin-associated lactic acidosis, which has been linked to severe outcomes including death, hypothermia, hypotension, and resistant bradyarrhythmias.

Background

Synjardy is a prescription medication that combines empagliflozin, an SGLT2 inhibitor, and metformin hydrochloride, a biguanide. It is used in the management of type 2 diabetes. The newly added boxed warning specifically addresses the risks associated with the metformin hydrochloride component. Metformin-associated lactic acidosis is a rare but serious metabolic complication that can occur due to metformin accumulation, particularly in patients with impaired renal function, congestive heart failure, or other conditions predisposing to hypoperfusion and hypoxia. The onset of metformin-associated lactic acidosis is often subtle, accompanied by non-specific symptoms such as malaise, myalgia, respiratory distress, somnolence, and abdominal distress. Laboratory findings often include decreased blood pH, increased anion gap, and elevated blood lactate levels.

What this means

The addition of a boxed warning to the Synjardy label underscores the critical importance for healthcare professionals to be vigilant for the signs and symptoms of metformin-associated lactic acidosis. Clinicians prescribing Synjardy, or its extended-release form Synjardy XR, must carefully assess patient risk factors, including renal function, before initiation and during treatment. The warning emphasizes that postmarketing cases have resulted in severe outcomes, including death. Patient education regarding the symptoms of lactic acidosis and when to seek immediate medical attention is also crucial. This label change reinforces the need for careful monitoring and appropriate management strategies to mitigate this serious adverse event.

Source

The information regarding this label revision was obtained from the FDA, as detailed in the drug label for Synjardy (setid=0fdd0255-0055-65f3-b2c0-db8fbb87beae) on January 30, 2026, hosted on dailymed.nlm.nih.gov.