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# Public Citizen Asks Diabetes Drug Boxed Warning
- URL: https://www.fdaweb.com/public-citizen-asks-diabetes-drug-boxed-warning/
- Published: 2020-06-24T12:00:00.000Z
- Updated: 2026-09-14T16:19:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147078

Public Citizen is petitioning FDA to require a Boxed Warning for all sodium-glucose cotransporter-2 (SGLT-2) inhibitor drugs contraindicating their use in patients with Type 1 diabetes. “There is irrefutable evidence from multiple randomized clinical trials that the SGLT-2 inhibitors canagliflozin (Janssen’s Invokana), dapagliflozin (AstraZeneca’s Farxiga), and empagliflozin (Boehringer Ingelheim’s Jardiance) — which are approved for treatment of adults with Type 2 diabetes but not Type 1 diabetes … — cause a significant increase in the incidence of life-threatening diabetic ketoacidosis (DKA) when administered to patients with Type 1 diabetes,” the [petition](https://www.citizen.org/wp-content/uploads/2529.pdf?eType=EmailBlastContent&eId=7f961a1c-de51-4a03-bc1e-f3518a06788a&ref=fdaweb.com) says.

The advocacy group says that the current off-label prescribing of these drugs to patients with Type 1 diabetes, which it says has been well documented by FDA, “is enabled by the dangerous incompleteness and submerged prominence of the warnings about the risk of DKA in the drugs’ current product labeling.”

In addition to a Boxed Warning, the petition asks for the addition of cautionary language in other sections of the labeling.

A Public Citizen media [statement](https://www.citizen.org/news/fda-must-warn-patients-doctors-of-potentially-deadly-complications-from-common-diabetes-drugs/?ref=fdaweb.com) says that since 2013 FDA has received 550 reports of DKA in patients with Type 1 diabetes who were treated with the drugs. “Most of these cases resulted in hospitalization (411 cases),” the statement says, “and many were considered life-threatening (68 cases).”