June 15, 2015 — The European Medicines Agency (EMA) has reported 101 cases of diabetic ketoacidosis worldwide in patients who used a medication in a new class of diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
The EMA has also launched a safety review to evaluate the risk of ketoacidosis and decide whether any changes are needed in the way these medications are used.
The agency warned:
“All cases were serious and some required hospitalisation. Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.”
Medications in the SGLT2 inhibitor class include:
- Invokana (canagliflozin)
- Invokamet (canagliflozin and metformin)
- Farxiga (dapagliflozin)
- Xigduo XR (dapagliflozin and metformin extended-release)
- Jardiance (empagliflozin)
- Glyxambi (empagliflozin and linagliptin)
Just a few weeks before the EMA announcement, the U.S. Food and Drug Administration (FDA) warned that 20 cases of ketoacidosis had been reported in the first year that SGLT2 inhibitors were on the market.
The FDA recommended that patients on these medications should be aware of the risk of ketoacidosis, even if blood-sugar levels were not especially high, and seek emergency medical attention for symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.
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