The U.S. Food and Drug Administration recently warned that certain type-2 diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors can result in ketoacidosis, a serious diabetic complication that requires hospitalization.

Acidosis is a medical condition in which a person’s body fluid experiences an increase in acidity. Ketoacidosis occurs when the body produces high level of blood acids known as ketones in body fluid. When insulin levels are too low or when a person goes through prolonged periods of fasting, ketones can build up inside the body.

FDA Diabetes Medication Warning

The FDA diabetic medicine warningspecifically names diabetes treatments including anagliflozin (manufactured by Invokana and Johnson & Johnson), dapagliflozin (manufactured by Farxiga and AstraZeneca), and empagliflozin (a Jardiance Lilly/Boehringer product), along with three other combination diabetes medicines that feature SGLT2 inhibitors.

According to data pulled from the FDA’s Adverse Event Reporting System (AERS) database, there have been 20 cases of diabetic ketoacidosis, ketoacidosis, or ketosis in diabetic patients treated with SGLT2 inhibitor diabetic medications between March 2013 and June 6, 2014.

The FDA notes that is not common for patients being treated for type-2 diabetes to develop ketoacidosis, and that the diabetic ketoacidosis cases reported to AERS were “atypical in that glucose levels were only mildly elevated at less than 200 mg/dL in some reports, while patients with type 1 diabetes who have DKA typically have glucose levels greater than 250 mg/dL,” according to FDA diabetes medication warning.

Diabetes Ketoacidosis Symptoms and Treatment

Some signs of ketoacidosis that type-2 diabetes patients should look out for include:

• Nausea
• Vomiting
• Difficulty breathing
• Stomach pain
• Confusion
• Fatigue and sleepiness

The FDA has advised medical professionals to evaluate the presence of acidosis and ketoacidosis in patients who experience those symptoms, and discontinue the SGLT2 diabetes medication if an acidosis diagnosis is confirmed.

All of the diabetic ketoacidosis cases reported to the FDA’s AERS database required the patients to be hospitalized. According to the agency’s data, most symptoms of diabetic ketoacidosis began to present about two weeks after a patient began type-2 diabetes treatment.

Since June 2014, the federal agency has continued to receive an influx of ketoacidosis reports involving type-2 diabetes patients using a SGLT2 diabetes medication. The FDA states, “We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs,” according to its diabetic medicine warning.

Diabetes Medication Lawsuits

At this time, attorneys are investigating the possibility of filing Invokana diabetic ketoacidosis lawsuits against Johnson & Johnson, claiming that the drug maker knew or should have known of the high risk of diabetic ketoacidosis associated with their diabetes medication but failed to provide adequate warning in an effort to protect their own profits. In addition to ketoacidosis, other diabetic medication injuries include renal failure and heart attacks.