FDA Must Warn Patients, Doctors of Potentially Deadly Complications From Common Diabetes Drugs

Failure to Adequately Acknowledge Risks to Type 1 Diabetes Patients Has Led to Serious Patient Harms

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must immediately require much stronger warning labels for commonly used Type 2 diabetes drugs known as SGLT2 inhibitors, as they can lead to potentially fatal diabetic ketoacidosis in Type 1 diabetes patients for whom the drugs are not approved, Public Citizen said today in a petition to the agency.

Eight randomized, placebo-controlled clinical studies by the pharmaceutical industry have found that SGLT2 inhibitors cause a more than threefold increase in the risk of diabetic ketoacidosis in patients with Type 1 diabetes, which can lead to acute kidney injury, respiratory failure and death. Although these studies were intended to get FDA approval for treating Type 1 diabetes patients, despite the unacceptable dangers, many physicians prescribe the drugs off-label for such patients.

Since 2013, the FDA has received 550 reports of diabetic ketoacidosis in patients with Type 1 diabetes who were treated with these drugs. Most of these cases resulted in hospitalization (411 cases), and many were considered life-threatening (68 cases). The petition asks the FDA to significantly upgrade the current, inadequate warning about this risk by replacing it with a prominent black box warning – the strongest warning that the agency can require for any drug explicitly advising that these drugs should never be used to treat Type 1 diabetes patients.

These well-documented risks have led the agency to reject requests from both companies seeking approval of SGLT2 drugs for treating Type 1 diabetes patients. SGLT2 inhibitors currently approved by the FDA only for Type 2 diabetes include canagliflozin (INVOKANA), dapagliflozin (FARXIGA), empagliflozin (JARDIANCE) and ertugliflozin (STEGLATRO).

“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,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group who drafted the petition. “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.”

Read the full petition here.