The consumer rights advocacy group, Public Citizen, filed a petition with the U.S. Food & Drug Administration (FDA) on June 24, asking to add stronger warning labels for commonly used type 2 diabetes drugs known as SGLT2 inhibitors like Invokana, Farxiga, Jardiance, and other similar drugs, which have been linked to serious and potentially life-threatening cases of diabetic ketoacidosis.
According to the petition filed, the group wants the warnings to indicate that type 1 diabetes patients may face the risks of fatal diabetic ketoacidosis associated with the medications, which are often prescribed “off label” to type 1 diabetic.
Diabetic ketoacidosis (DKA) happens when the blood sugar is very high, and acidic substances called ketones build up to dangerous levels in the body. DKA is a serious complication of type 1 diabetes and less common in type 2 diabetes, but a rise in the risk has been reported in the patients consuming type 2 drugs.
The group indicated that the FDA received 550 reports of diabetic ketoacidosis in patients suffering from type 1 diabetes who were treated with SGLT-2 inhibitors, and it was found that 411 cases resulted in hospitalization, and 68 had life-threatening conditions. It also noted that eight randomized, placebo-controlled clinical studies determined Invokana and other similar drugs increased the risk of diabetic ketoacidosis in type 1 diabetics by a factor of three.
Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group who drafted the petition, in a press release, said, "For several years, the FDA has become increasingly aware of serious life-threatening diabetic ketoacidosis caused by these drugs when prescribed for Type 1 diabetes patients. It’s long overdue, but the agency must explicitly oppose the use of these drugs for patients with Type 1 diabetes with a prominent boxed warning. Further delay guarantees additional, preventable drug-induced diabetic ketoacidosis for these patients."
Invokana (Canagliflozin) is a drug used for the treatment of type 2 diabetes. It was developed by Mitsubishi Tanabe Pharma and is marketed under license by Janssen, a division of Johnson & Johnson in the United States. The FDA approved Invokana on March 29, 2013, for the treatment of type 2 diabetes. It belongs to the class sodium-glucose cotransporter 2 (SGLT2) inhibitor. Glucose is reabsorbed from urine by the action of SGLT2, which is an enzyme in the kidney tubule; by inhibiting the action of SGLT2, Invokana helps the kidneys get rid of glucose from the bloodstream.
Several Invokana lawsuits were filed in courts nationwide against the manufacturer Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. Most of the lawsuits previously filed alleging that the manufacturer failed to warn about the diabetic ketoacidosis risk have been settled.
