After receiving numerous adverse event reports, the U.S. Food and Drug Administration is warning patients and the medical community that some type-2 diabetes treatments may lead to ketoacidosis and kidney failure.

The FDA specifically noted sodium­ glucose cotransporter­2 (SGLT2) inhibitors may increase the risk of ketoacidosis or ketosis in patients.

Some of the SGLT2 medications include:

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

SGLT2 inhibitors are FDA approved to treat patients with type-2 diabetes. The medication works by causing the kidney to remove sugar from the body and secreting it in the urine. SGLT2 inhibitors are most effective when combined with diet and exercise to lower blood sugar levels.

What is Diabetic Ketoacidosis?

Ketoacidosis occurs when the body produces high levels of blood acids (ketones). When the body does not have enough insulin for energy, it will break down fat and release ketones.

If ketones build up in the blood, it becomes more acidic which can lead to ketoacidosis. This is a serious medical condition that can lead to diabetic comas or even death. Patients who develop ketoacidosis require hospitalization in order to treat the condition.

While ketoacidosis is not usually found in type-2 diabetes patients, in all the cases reported to the FDA the average time of onset symptoms was two weeks after starting an SGLT2 inhibitor.

The FDA warns those taking an SGLT2 medication should watch for the following ketoacidosis symptoms which include:

• Nausea
• Vomiting
• Difficulty breathing
• Confusion
• Abdominal pain
• Unusual fatigue and sleepiness

The federal agency urges medical professionals to check for acidosis in patients taking a SGLT2 inhibitor and recommends discontinuing use of SGLT2 inhibitors, if ketoacidosis is confirmed.

The FDA adverse event database has confirmed 20 cases of diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients using a SGLT2 inhibitor. The federal agency states that they will continue to investigate the safety concerns of SGLT2 inhibitors to determine if any label changes or prescribing information needs to be adjusted.

The FDA continues to receive reports of diabetic ketoacidosis in patients treated with the SGLT2 inhibitors. Currently, there are personal injury attorneys looking for diabetic patients who took one of the many SGLT2 inhibitor medications and developed life-threatening side effects including ketoacidosis, ketosis or renal failure.