Off-Label Use of Non-insulin Therapies for Type 1 Diabetes during Cold and Flu Season

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Do you know whether you ever been prescribed medication “off-label”? Each prescription drug has a label that describes its FDA-approved uses, which are based on well-designed clinical trials that carefully determined the risks as well as the benefits of the medication. Using a drug “off-label” means that the drug is being used for a condition where studies of its risks and benefits have not yet been carried out.

Dr. Anne Peters of the University of Southern California’s Center for Diabetes recently observed that some patients with type 1 diabetes (T1D) who were taking Invokana™ (canagliflozen tablets) “off-label” have experienced diabetic ketoacidosis (DKA) while managing a cold or flu. Invokana is an SGLT2-inhibitor treatment approved by the FDA for treatment in type 2 diabetes (T2D). It works to keep blood glucose levels from going too high by increasing the excretion of glucose in the urine. That’s okay if you have T2D because patients with T2D rarely develop DKA; it’s potentially an issue if you have T1D.

People with T1D can develop DKA because they are not getting any insulin (for example, an infusion site problem in patients who use a pump) or aren’t getting enough insulin due to the stress of an illness like the flu. In these cases, they are alerted that DKA may be developing by unexpected and/or persistent increases in blood glucose levels. Such high blood glucose levels should prompt you to test for ketones in the urine or blood. What is different for people with T1D who are taking Invokana is that the warning sign of high blood glucose levels can be lost and DKA can develop with normal blood sugar levels. In fact, instead of taking extra insulin (which is often needed to prevent DKA when you have the cold or flu), Dr. Peters’ patients lowered their insulin dose, which made things worse.

The important message is that if you have type 1 diabetes and are taking Invokana or any other type of SGLT2-inhibitor such as Farxiga™ (dapagliflozin) or Jardiance® (empagliflozin) and have a cold, other illness or feel sick to your stomach (one of the key symptoms of high ketone levels), you should be aware that you may be at risk for DKA even with normal blood sugar levels. Of course, check with your own doctor if you have any questions. Dr. Peters offers her patients the following advice based on her observations:

  1. Understand the risks and stop the medication if you are concerned.
  2. Be sure to have ketone test strips at home. They don’t require a prescription.
  3. If you come down with any illness: fever, head cold, runny nose, nausea, etc., stop taking the medication and measure urine ketones every 6 to 8 hours.
  4. Do not restart the medication until you are well and the ketones are gone. You will need to give extra insulin, which is the right thing to do when you are sick.
  5. If you have urine ketones that are more than trace positive, then contact your healthcare provider right away.

If you have any doubt or questions, contact your doctor immediately. You may be advised to stop the medication, drink lots of fluids, and give insulin regularly.


Farxiga is a trademark of the AstraZeneca group of companies. Jardiance is a registered trademark of Boehringer Ingelheim International GmbH & Co. Other trademarks are those of their respective owners.

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