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FDA issues warning on new class of Type-2 diabetes medications

The newer class of type-2 diabetes medications are sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim. The FDA says they may cause dangerously high levels of blood acids requiring hospitalization.

These medications belong to a class of prescription drugs called SGLT2 (sodium-glucose cotransporter-2) inhibitors. They work by causing the kidneys to secrete sugar in the urine. This class of drugs has been approved by the FDA for use with diet and exercise to lower blood sugar levels in patients with type-2 diabetes.

The products are available as a single-ingredient medicine or in a combination with other diabetes drugs. The safety of these medications has not been established for patients with type-1 diabetes and are not approved for use in type-1 diabetes by the FDA. Below is a list of the SGLT2 medications covered under the FDA warning.

List of SGLT2 inhibitors

List of SGLT2 inhibitors
FDA


The FDA’s “Adverse Event Reporting System” database picked up on the ketoacidosis problem, identifying 20 cases of ketoacidosis in patients using medications with SGLT2 inhibitors between March 2013 to June 6, 2014. All the patients required an emergency room visit and some patients had to be admitted to the hospital for treatment.

The FDA continued to receive reports of ketoacidosis after June, 2014. Elevated levels of ketones can be subdivided into “diabetic ketoacidosis,” or DKA, and ketoacidosis, or ketosis. DKA is a type of acidosis that develops when the levels of insulin in the body become too low. The thing is, DKA is usually seen in Type-1 diabetics, along with very elevated blood sugars.

The elevated DKA levels reported under the FDA’s Adverse Event Reporting System were all people with type-2 diabetes taking SGLT2 inhibitors. It was also found that the patients did not have greatly elevated blood sugar levels. This important finding is being investigated by the FDA. In a statement, the agency says: “We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs.”

Signs of ketoacidosis to watch for
Signs of ketoacidosis include difficulty breathing, nausea and vomiting, abdominal pain, unusual fatigue or tiredness. The FDA says: “Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.”

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We are deeply saddened to announce the passing of our dear friend Karen Graham, who served as Editor-at-Large at Digital Journal. She was 78 years old. Karen's view of what is happening in our world was colored by her love of history and how the past influences events taking place today. Her belief in humankind's part in the care of the planet and our environment has led her to focus on the need for action in dealing with climate change. It was said by Geoffrey C. Ward, "Journalism is merely history's first draft." Everyone who writes about what is happening today is indeed, writing a small part of our history.

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