May 15, 2015 — A new class of diabetes drugs have been linked to a life-threatening side effect known as diabetic ketoacidosis according to a Safety Communication issued by the FDA.
The medications belong to a class known as SGLT2 inhibitors, which help lower blood-sugar levels by helping the kidneys excrete sugar in urine. The first SGLT2 inhibitor, Invokana, was introduced by Johnson & Johnson’s Janssen Pharmaceuticals unit in March 2013.
Between March 2013 and June 2014, the FDA received 20 reports of ketoacidosis in patients who used an SGLT2 inhibitor.
Ketoacidosis is caused by a serious buildup of waste products known as ketones in the body. It occurs when the body is unable to use glucose (sugar) in the bloodstream due to a lack of insulin, which forces the body to break down fat cells instead.
Diabetes drugs 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)
The FDA recommends that patients on SGLT2 inhibitors take the following precautions:
“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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