FDA Warns About Ketosis Risk from New Diabetes Drugs

May 15, 2015 — The FDA has issued a Safety Communication to warn about the risk of ketosis, a possibly life-threatening side effect of certain diabetes drugs.

The warning was issued after the FDA identified 20 cases of diabetic ketoacidosis in patients treated with a class of diabetes medications known as SGLT2 inhibitors between March 2013 and June 2014.

List of SGLT2 inhibitors:

• Invokana (canagliflozin)
• Invokamet (canagliflozin and metformin)
• Farxiga (dapagliflozin)
• Xigduo XR (dapagliflozin and metformin extended-release)
• Jardiance (empagliflozin)
• Glyxambi (empagliflozin and linagliptin)

This new class of drugs hit the market when the FDA approved Invokana in March 2013. They treat type-2 diabetes by helping the kidneys remove sugar through the urine, which helps lower blood-sugar levels.

Diabetic ketoacidosis is normally associated with type-1 diabetes rather than type-2. It occurs when the body cannot use sugar (glucose) in the blood as a fuel source because there is too little insulin, and starts breaking down fat cells instead. This releases waste products called ketones, which build up in the body and cause health problems.

For patients on these medications, the FDA recommends:

“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.”

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