The U.S. Food and Drug Administration (FDA) updated the label for dapagliflozin on 2026-05-13. This revision specifically modifies the 'Indications and Usage' section. The updated label now includes an indication to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
Background
The updated indication for dapagliflozin addresses the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus. This patient population, especially those with established cardiovascular disease or multiple cardiovascular risk factors, faces a heightened risk of cardiovascular events, including heart failure.
Key results
The updated 'Indications and Usage' section of the dapagliflozin label states that the tablets are indicated: 'To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.'
What this means
This label update provides clinicians with a clear indication for using dapagliflozin to address a specific cardiovascular risk in patients with type 2 diabetes mellitus. The ability to reduce the risk of hospitalization for heart failure represents an important therapeutic option for patients who also have established cardiovascular disease or multiple cardiovascular risk factors. This expanded indication supports the use of dapagliflozin beyond its traditional role in glycemic control, highlighting its broader cardiorenal protective benefits.
Source
The information for this label revision was sourced from the U.S. Food and Drug Administration (FDA). The updated indication and usage details for dapagliflozin were made effective on 2026-05-13 and are available on dailymed.nlm.nih.gov.