Federal health officials are warning that a new class of Type 2 diabetes medication may lead to a serious, potentially fatal condition in which the body overproduces a chemical called ketone and results in too much acid in the blood.
An investigation will determine whether changes are needed in the prescribing information for the class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, the Food and Drug Administration said in a safety alert issued Friday.
Between March 2013 and June 6, 2014, the FDA's adverse-event database identified 20 cases where patients treated with the medications developed diabetic ketoacidosis and required either an emergency room visit or hospitalization.
The agency has continued to receive adverse-events reports over the past year, which raised flags because the condition is most common in patients with Type 1 diabetes. Healthcare professionals and patients are being urged to report SGLT2 inhibitor side effects to the FDA's MedWatch program.
SGLT2 inhibitors are approved for use with diet and exercise to lower blood sugar in adults with Type 2 diabetes. It works by causing the kidneys to remove sugar from the body through the urine.
In March 2013, the drug Invokana (canagliflozin) by Janssen Pharmaceuticals' became the first in this new class of diabetes medication to receive FDA approval for use of the drug in Type 2 diabetics. Safety and effectiveness were determined based on nine clinical trials involving more than 10,200 patients.
The FDA has since approved five other drugs, all listed on Friday's alert. They include Janssens' Invokamet, AstraZeneca's Farxiga and Xigduo XR and Boehringer Ingelheim's Jardiance and Glyxambi.