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World Diabetes Day 2015

Carol Baldwin

Last updated: November 2, 2016 3:13 pm

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November 14, 2015 is World Diabetes Day (WDD). According to its sponsor, the International Diabetes Foundation (IDF), WDD kicks off a year-long campaign to raise awareness and understanding of diabetes.  During this year, IDF hopes to “reflect the realities of dealing with a chronic condition.” 1

One of those realities is the risk of developing a life-threatening condition called diabetic ketoacidosis (DKA). DKA is a chemical imbalance that occurs when the body is unable to get glucose (sugar) — the body’s primary form of energy — into its cells because it does not have enough insulin. 2

During DKA, because cells are not able to use glucose, sugar stays in the blood, where it is filtered by the kidneys and excreted in urine.  Since the body cannot access sugar for energy, it begins to break down muscle and fat in order to meet its energy needs. As this occurs, fatty acids are broken down, releasing ketones into the blood stream, resulting in a chemical imbalance. 3

Signs and Symptoms of DKA

World Diabetes Day draws attention to the risks of DKA, as well as its signs. These signs include:

  • Belly pain
  • Blurred vision
  • Confusion
  • Decreased appetite
  • Drowsiness or difficulty waking up
  • Flushed, hot, dry skin
  • Frequent urination
  • Fruity breath odor
  • Rapid, deep breathing
  • Thirst
  • Vomiting 4

Detecting ketones in the urine is usually a simple process, frequently done at home through the use of test strips, which are available by prescription.  Be aware, however, that severe DKA can require emergency room treatment or hospitalization. 5

SGLT2 Inhibitors and Diabetes

Very recently, DKA has been associated with some medications approved for the treatment of type 2 diabetes (intended to be taken in addition to diet and exercise treatment). These medications are known as sodium glucose cotransporter-2 (SGLT2) inhibitors.

According to the U.S. Food and Drug Administration (FDA) in a recent Safety Communication, “SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.”  6

The FDA goes on to say that SGLT2 inhibitors include the drugs canagliflozin, dapagliflozin and empagliflozin — sometimes in combination with other medications — which are sold under the brand names Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.  7

Adverse events in diabetes patients taking SGLT2 inhibitors have been reported regarding diabetic ketoacidosis.  In response, the FDA issued a Safety Communication regarding SGLT2 inhibitors and diabetic ketoacidosis on May 15, 2015.

FDA Warning About SGLT2 Inhibitors and DKA

In the Safety Announcement the FDA warned, “…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.” 8

What the FDA found alarming was the fact that for the adverse event reports it examined, DKA occurred even when blood sugar levels were not extremely elevated.  The FDA noted, “DKA…is a type of acidosis that usually develops when insulin levels are too low or during prolonged fasting. DKA most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels.” 9  Yet, the reported cases of adverse events examined, “…were not typical for DKA because most of the patients had type 2 diabetes and their blood sugar levels, when reported, were only slightly increased compared to typical cases of DKA.” 10

The FDA recommends that diabetic patients taking SGLT2 inhibitors “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.” 11

  1. International Diabetes Foundation. (2015). http://www.idf.org/wdd-index. Accessed September 26, 2015. 

  2. WebMD. (2015). Diabetes Health Center, Diabetic Ketoacidosis (DKA) –Topic Overview. http://www.webmd.com/diabetes/tc/diabetic-ketoacidosis-dka-topic-overview. Accessed September 26, 2015. 

  3. WebMD. (2015). Diabetes Health Center, Diabetic Ketoacidosis (DKA) –Topic Overview. http://www.webmd.com/diabetes/tc/diabetic-ketoacidosis-dka-topic-overview. Accessed September 26, 2015. 

  4. WebMD. (2015). Diabetes Health Center, Diabetic Ketoacidosis (DKA) –Topic Overview. http://www.webmd.com/diabetes/tc/diabetic-ketoacidosis-dka-topic-overview. Accessed September 26, 2015 

  5. WebMD. (2015). Diabetes Health Center, Diabetic Ketoacidosis (DKA) –Topic Overview. http://www.webmd.com/diabetes/tc/diabetic-ketoacidosis-dka-topic-overview. Accessed September 26, 2015 

  6. Food and Drug Administration Safety Communication. (May 15, 2015). FDA warns that SGLT2 inhibiters for diabetes may result in a serious condition of too much acid in the blood. http://www.fda.gov/drugs/drugsafety/ucm446845.htm. Accessed September 26, 2015. 

  7. Food and Drug Administration Safety Communication. (May 15, 2015). FDA warns that SGLT2 inhibiters for diabetes may result in a serious condition of too much acid in the blood. http://www.fda.gov/drugs/drugsafety/ucm446845.htm. Accessed September 26, 2015. 

  8. Food and Drug Administration Safety Communication. (May 15, 2015). FDA warns that SGLT2 inhibiters for diabetes may result in a serious condition of too much acid in the blood. http://www.fda.gov/drugs/drugsafety/ucm446845.htm. Accessed September 26, 2015. 

  9. Food and Drug Administration Safety Communication. (May 15, 2015). FDA warns that SGLT2 inhibiters for diabetes may result in a serious condition of too much acid in the blood. http://www.fda.gov/drugs/drugsafety/ucm446845.htm. Accessed September 26, 2015. 

  10. Food and Drug Administration Safety Communication. (May 15, 2015). FDA warns that SGLT2 inhibiters for diabetes may result in a serious condition of too much acid in the blood. http://www.fda.gov/drugs/drugsafety/ucm446845.htm. Accessed September 26, 2015. 

  11. Food and Drug Administration Safety Communication. (May 15, 2015). FDA warns that SGLT2 inhibiters for diabetes may result in a serious condition of too much acid in the blood. http://www.fda.gov/drugs/drugsafety/ucm446845.htm. Accessed September 26, 2015.