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May 2015 Diabetes Drugs – Ketoacidosis Link Warning By FDA Covers Invokana, Farxiga, And Jardiance, With Label Changes Possible

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Case Reports Of These Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Causing Diabetic Ketoacidosis (DKA) Presented At Recent Medical Meeting

 
SUMMARY: The FDA is investigating a connection between a certain class of diabetes medicines and diabetic ketoacidosis (DKA), ketoacidosis, or ketosis. From “FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood”, issued on May 15, 2012:

The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines [Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin)] may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization….

Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness….

In addition, at least one study presented at the 2015 annual meeting of the American Association of Clinical Endocrinologists found a connection between the SGLT2 inhibitors and diabetic ketoacidosis (DKA), according to this MedPage Today news report, “Three Diabetes Drugs Linked to Ketoacidosis, FDA Warns”,

We will continue to monitor the safety profile of these SGLT2 inhibitors — Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin) — as regards side effects such as cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients using these drugs as diabetes treatments.

[Read this article in full at original source]

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