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Petition to the FDA to Require a Black-Box Warning for Commonly Used Type 2 Diabetes Drugs Known as SGLT2 Inhibitors

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Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the 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.

June 24, 2020, FDA acknowledgment letter.

December 18, 2020, FDA interim response letter.