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Medication Safety Alerts

SGLT2 Inhibitors FDA Drug Safety Communication

05/15/2015

On May 15, 2015, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication warning that the type 2 diabetes medicines Invokana®, Invokamet®, Farxiga®, Xigduo® XR, Jardiance® and Glyxambi® may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may cause hospitalization.

The FDA recommends that plan members 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. Members should not stop or change their diabetes medicines without first talking to their doctor. The FDA has provided the following information for members:

  • Acidosis is when there is too much acid in the body. Diabetic ketoacidosis and ketoacidosis, serious conditions in which the body produces high levels of blood acids called ketones, have been reported in patients using the diabetes medicines known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Ketones can build up in the body if insulin levels are too low or during prolonged fasting.
  • Pay close attention for any signs or symptoms of acidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Seek medical attention immediately if you experience any of these symptoms.
  • Ketoacidosis associated with SGLT2 inhibitors may be present even if the blood sugar is not very high.
  • The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and the FDA has not approved them for use in these patients.
  • Do not stop or change your diabetes medicines without first talking to your health care professional. When untreated, diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
  • Read the patient Medication Guide or Patient Package Insert you receive with your SGLT2 inhibitor prescription. They explain the benefits and risks associated with the use of the medicine.
  • Talk to your doctor if you have questions or concerns about SGLT2 inhibitors or any of your other diabetes medicines.
  • Report side effects from SGLT2 inhibitors to the FDA.

A complete list of product affected by this issue is available here:

Do not stop taking your medicine without talking to your doctor. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

If you would like more information about this issue, please call the FDA consumer inquiry line toll-free at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/Safety/MedWatch.

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