SGLT2 inhibitors: Drug Safety Communication – FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood

English: The blue circle is the global symbol ...
English: The blue circle is the global symbol for diabetes, introduced by the International Diabetes Federation with the aim of giving diabetes a common identity, supporting existing efforts to raise awareness of diabetes and placing the diabetes epidemic firmly in the public spotlight. (Photo credit: Wikipedia)


ISSUE: FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.


BACKGROUND: SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.


These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin.


RECOMMENDATION: 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. Do not stop or change  your diabetes medicines without first talking to your prescriber.


Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels. See the FDA Drug Safety Communication for more information.


Prevencion cardiovascular en diabeticos: Documento de la American Heart Association & American Diabetes Association

Primary Prevention of Cardiovascular Diseases in People With Diabetes Mellitus: A Scientific Statement From the American Heart Association and the American Diabetes Association.

AHA/ADA Scientific Statement

Circulation. 115(1):114-126, January 2/9, 2007.
Buse, John B. MD, PhD, Co-chair; Ginsberg, Henry N. MD, FAHA, Co-chair; Bakris, George L. MD, FAHA; Clark, Nathaniel G. MD, MS, RD; Costa, Fernando MD, FAHA; Eckel, Robert MD, FAHA; Fonseca, Vivian MD; Gerstein, Hertzel C. MD, MSc, FRCPC; Grundy, Scott MD, FAHA; Nesto, Richard W. MD, FAHA; Pignone, Michael P. MD, MPH; Plutzky, Jorge MD; Porte, Daniel MD; Redberg, Rita MD, FAHA; Stitzel, Kimberly F. MS, RD; Stone, Neil J. MD, FAHA

mdash;: The American Heart Association (AHA) and the American Diabetes Association (ADA) have each published guidelines for cardiovascular disease prevention: The ADA has issued separate recommendations for each of the cardiovascular risk factors in patients with diabetes, and the AHA has shaped primary and secondary guidelines that extend to patients with diabetes. This statement will attempt to harmonize the recommendations of both organizations where possible but will recognize areas in which AHA and ADA recommendations differ.

(C) 2007 American Heart Association, Inc.