FDA Warns of Blood Acids from SGLT2 Drugs

By Rheingold Giuffra Ruffo & Plotkin LLP

The FDA warned last week that a commonly used newer class of type 2 diabetes drugs may cause dangerously high levels of blood acids that could require hospitalization. The sodium-glucose cotransporter-2 (SGLT2) inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. The SGLT2s include AstraZeneca’s Farxiga (dapagliflozin), Johnson & Johnson’s Invokana (canagliflozin) and Eli Lilly in partnership with Boehringer Ingleheim’s Jardiance (embagliflozin).

SGLT2s are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. The FDA warned on its website that SGLT2s may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids known as ketones. The FDA reported 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors. All cases required treatment of an emergency room visit or hospitalization.

The FDA continues to receive additional adverse event reports in patients taking SGLT2s. Patients should pay attention for signs of ketoacidosis, such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. The FDA warning also listed three combination drugs which include an SGLT2: Invokamet, Xigduo XR, and Glyxambi.

The SGLT2s became particularly popular because they generally lead to modest weight loss and slightly lower blood pressure as opposed to some older treatments which caused weight gain.

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