Euglycemic Diabetic Ketoacidosis: Hidden in Plain Sight

Area of Science:

• Endocrinology
• Metabolic Disorders
• Pharmacovigilance

Background:

• Euglycemic diabetic ketoacidosis (euDKA) is a rare metabolic state characterized by normal plasma bicarbonate (>10 mEq/L) and low blood glucose (<300 mg/dL).
• Historically, euDKA has been infrequently reported, with a notable resurgence in recent years.
• Unlike classic diabetic ketoacidosis, euDKA presents without significant hyperglycemia, potentially delaying diagnosis.

Purpose of the Study:

• To investigate the association between SGLT-2 inhibitors and the occurrence of euglycemic diabetic ketoacidosis.
• To inform healthcare providers and regulatory bodies about the emerging risk of euDKA with SGLT-2 inhibitor use.

Main Methods:

• Analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database.
• Review of reported cases linking euDKA episodes to SGLT-2 inhibitor medications over a two-year period.

Main Results:

• A total of 73 euDKA episodes were identified and linked to SGLT-2 inhibitor use within the study period.
• The FDA issued a safety warning in May 2015 and updated drug labeling in December 2015 to reflect the increased risk of euDKA.

Conclusions:

• SGLT-2 inhibitors are associated with an increased risk of developing euglycemic diabetic ketoacidosis.
• Healthcare professionals, patients, and caregivers must maintain heightened awareness of euDKA as a potential adverse effect.
• Prompt recognition and management are critical, as euDKA can be a life-threatening condition.