FDA Should Reject Dangerous New Diabetes Medication

Jan. 17, 2019

FDA Should Reject Dangerous New Diabetes Medication

Dr. Sidney Wolfe, Founder and Senior Adviser of Public Citizen’s Health Research Group, Urges Rejection of Sotagliflozin

The U.S. Food and Drug Administration (FDA) is considering approving a new type 1 diabetes treatment called Zynquista (sotagliflozin) that is intended to improve blood sugar control in patients. Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, is testifying today in front of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and will urge the panel to recommend that the agency not approve the medication.

The medication, developed by Sanofi, offers no more than small benefits that don’t outweigh the large, dangerous increased risk of diabetic ketoacidosis, a serious complication of type 1 diabetes that results in excess acid in the blood.

Read Wolfe’s testimony here (PDF).

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