FDA issues warning for type 2 diabetes drugs

FDA issues warning for type 2 diabetes drugs
SGLT2 inhibitors linked to potentially fatal condition called ketoacidosis.

(HealthDay)—A certain class of type 2 diabetes drugs can lead to a life-threatening condition called ketoacidosis, the U.S. Food and Drug Administration warns.

These are called sodium-glucose cotransporter-2 (SGLT2) inhibitors and include canagliflozin, dapagliflozin and empagliflozin. They work by prompting the kidneys to remove sugar in the blood through urine.

The drugs are sold under the brand names: Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended-release), Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin).

Between March 2013 and June 2014, the FDA received 20 reports of the drugs triggering , in which levels of blood acids called ketones are too high. If untreated, ketoacidosis can lead to a diabetic coma or even death, according to the American Diabetes Association.

All 20 patients had to go to an emergency department or were hospitalized, the FDA said.

Ketoacidosis typically affects people with type 1 diabetes, but all of these cases involved people with type 2 diabetes and the condition manifested itself slightly differently than in people with type 1 diabetes, the FDA said in a news release.

The agency said it's investigating the issue to see if changes are needed in the prescribing information for SGLT2 inhibitors. The drugs are approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Patients taking SGLT2 inhibitors should monitor themselves for any signs of ketoacidosis and seek immediate medical attention if they develop symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness, the FDA said.

Ketones can be detected with a simple urine test using a test strip, similar to a blood testing strip, and you should ask your about when and how to test for ketones, according to the diabetes association.

Patients shouldn't stop or change their without first talking with their doctor. If ketoacidosis is confirmed in a patient, doctors should take the patient off SGLT2 inhibitor, take appropriate action to correct the condition and monitor sugar levels, the FDA advised.


Explore further

US panel backs novel diabetes pill from J&J (Update)

More information: The American Diabetes Association has more about diabetic ketoacidosis.

Copyright © 2015 HealthDay. All rights reserved.

Citation: FDA issues warning for type 2 diabetes drugs (2015, May 18) retrieved 22 July 2019 from https://medicalxpress.com/news/2015-05-fda-issues-diabetes-drugs.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
15 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more